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11+ FDA Jobs in India

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Synapsica Technologies Pvt Ltd

at Synapsica Technologies Pvt Ltd

6 candid answers
1 video
Human Resources
Posted by Human Resources
Bengaluru (Bangalore)
3 - 5 yrs
₹4L - ₹12L / yr
Regulatory affairs
data privacy
ISO/IEC 27001:2005
ISO 27001
soc2
+4 more

Job Title: QA Associate 

 

Job Description:

  1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
  2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
  3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

 

3-5 years of relevant experience in Medical Devices Industry.

 

 

Area of Expertise:

  • To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
  • Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
  • Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
  • Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
  • Manage all documentation related to internal and external audit.
  • Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
  • Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
  • Co-ordination of Management Review Meetings & its action items implementation

 

Experience Required:

  • 3-5 years of relevant experience in Medical Devices Industry.
  • Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
  • Ability to read and understand standard requirements independently.
  • Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
  • Good understanding of design control, and post marketing processes
  • Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
  • Working knowledge of an e-QMS is an added advantage.
Read more
Qiro Finance

at Qiro Finance

2 candid answers
Qiro Finance
Posted by Qiro Finance
Remote only
5 - 10 yrs
₹20L - ₹35L / yr
Capital Market
Regulatory affairs
Debt Finance
Equity
Investor relations
+4 more

Who we are:

At Qiro, we are a dynamic team united by a mission to foster a fair, transparent, and decentralized global lending market. Our focus lies in developing an institutional private credit protocol that seamlessly connects on-chain stablecoin lenders with off-chain fintech borrowers.


What are we looking for:

We are seeking a dynamic and experienced professional with 5-10 years of proven expertise in capital markets, preferably within the fintech or financial services industry. The ideal candidate will have a strong track record of raising capital from diverse sources and a deep understanding of global financial markets.


Responsibilities:

  • Lead the development and execution of capital raising strategies to support our global fintech lending operations.
  • Establish and maintain relationships with institutional investors, venture capital firms, and other key stakeholders.
  • Analyze market trends and identify opportunities for optimizing capital structures and funding sources.
  • Collaborate with senior leadership on strategic initiatives and investor relations activities.
  • Provide guidance and mentorship to the capital markets team to drive performance excellence.


Requirements:

  • 5+ years of experience in Capital Markets or Risk Operations at high-growth marketplaces/fintechs.
  • Have experience in Liquify and partnerships have relationships with hedge fund in the US and Europe.
  • Passion for technology, especially in marketplaces or fintech, web debt fund, structured debt and corporate financing.
  • Experience in fast-paced, ambiguous environments driving projects from strategy through implementation; happy to roll up your sleeves to get any job done.
  • Knowledge of capital markets funding and financing transactions.
  • Understands Treasury investment portfolio management, foreign currency risk, and counterparty credit risk evaluation.
  • Strong communication skills and ability to explain complex concepts effectively.
  • Ability to work cross-functionally with Sales, Product, Engineering, and other Operations teams to achieve business objectives.
  • Highly analytical - can drive complex analyses and manage projects to KPIs and metrics.


Nice to have:

  • Experience working with blockchain-based fintech companies.
  • Knowledge of securitization, structured finance, and alternative investments.
  • Professional certifications such as CFA or ACCA.


Benefits:

  • Competitive salary package with performance-based bonuses.
  • Exposure to cutting-edge fintech solutions and global market trends.
  • Flexible remote work.
  • Flexible working hours.
Read more
CyberNX Technologies
Bengaluru (Bangalore)
4 - 8 yrs
₹9L - ₹15L / yr
isms
ISO/IEC 27001:2005

Information Security Manager shall be primarily responsible to :

  • Run and manage the BAU security infosec operations
  • Create and maintain ISMS Policy and Process documents
  • Ensure Infosec compliance with RBI and other regulatory agencies
  • Participate in IT / Infosec Audits and ensure closure of observations within given timeliness
  • Conduct regular VAPT (Vulnerability Assessments) and track closure of open observations
  • Identifying and evaluating new IT security technologies and services and implementing it
  • Ensure cyber security related polices and technologies are in place
  • Conducting regular Inforsec Awareness within users in the organization
  • The person needs to work closely with the CISO and other stakeholders – Risk, IT and Audit teams.


Key Accountability:

  • Ensuring adequate security controls are in place & working effectively within the organization for information & cyber security
  • Ensuring effectiveness of all IT controls to prevent any unauthorized access or activities at a system administration level
  • Identify potential security weaknesses through vulnerability assessments and track them to closure within the timeliness
  • Tracking and reporting key risk indicators defined for IT processes
  • Create and maintain the documentation for information system audits in accordance with regulatory and compliance requirements
  • Create / Review ISMS policy and process
  • Implement Strategic IT Infosec projects to strengthen the overall IT Security posture

 

Read more
Thinksys Software

at Thinksys Software

1 recruiter
Harshita Saxena
Posted by Harshita Saxena
Pune
2 - 10 yrs
₹2L - ₹5L / yr
Quality audit

Position: Call Quality Analyst

 

Monitoring Calls:

 

Listen to recorded or live calls between customer service representatives and customers.

Evaluate the call based on predefined quality metrics and guidelines.

 

Quality Assessment:

 

  • Assess and score calls on various criteria, including but not limited to, professionalism, communication skills, adherence to scripts or protocols, problem-solving abilities, and compliance with company policies.
  • Feedback and Coaching:
  • Provide constructive feedback to call center agents on their performance, highlighting strengths and areas for improvement.
  • Offer coaching and training to help agents enhance their skills and meet quality standards.
  • Reporting and Documentation:
  • Maintain detailed records and documentation of evaluations, scores, feedback, and coaching sessions.
  • Generate regular reports on individual and team performance for management review.
  • Root Cause Analysis:
  • Identify recurring issues or trends in calls and collaborate with relevant departments (e.g., training, operations) to address and resolve 
  • Compliance and Policy Adherence:
  • Ensure that agents adhere to company policies, legal requirements, and industry regulations during customer interactions.
  • Process Improvement:
  • Propose improvements to call center processes, scripts, training materials, or policies based on insights gained from call evaluations.
  • Training and Development Support:
  • Assist in the development and delivery of training materials and programs for call center agents.
  • Conduct refresher training sessions on specific skills or areas identified for improvement.
  • Quality Assurance Metrics:
  • Collaborate with stakeholders to establish and refine key performance indicators (KPIs) for call quality.
  • Monitor and analyze performance metrics to ensure they align with organizational goals.
  • Stakeholder Communication:
  • Communicate findings, trends, and improvement recommendations to call center management, supervisors, and relevant departments.

 

Qualifications:

 

  • Minimum 2 years of experience as a Call Quality Analyst.
  • Previous experience in a call center or customer service role is often preferred.
  • Strong analytical skills and attention to detail.
  • Excellent communication skills, both written and verbal.
  • Proficiency in using call monitoring software and tools.
  •  Knowledge of industry-specific regulations and compliance standards (if applicable).


Read more
Hassan
1 - 5 yrs
₹2.5L - ₹3.5L / yr
Quality audit
Internal audit
Documentation
KPI

ROLE : BPO QUALITY ANALYST (QA)

EDUCATION: ANY DEGREE

EXPERIENCE: 1-5YRS (PREFERRED RELEVANT EXPERIENCE ONLY)

WORK FROM OFFICE: 24*7 (3 SHIFT/DAY-Rotational Shift)

NOTICE PERIOD : IMMEDIATE JOINEE

LOCATION : HASSAN, KARNATAKA


JOB DESCRIPTION:


BPO QUALITY ANALYST-Roles and Responsibilities


  • Strong analytical and facilitation skills.
  • Monitoring product standards and implementation of quality control programs.
  • The Quality Executive role is to ensure that the quality is maintained which is ensured through regular process compliance checks including both data as well as process audits.
  • Performing the internal audit cycle based on facts.
  • Planning, organizing, updating and maintaining documentation related to quality parameters.
  • Highly self-motivated and directed, with keen attention to detail.
  • Good time management skills
  • Keeping quality documentation up to date.
  • Analyzing the working progress of employees with set parameters.
  • Responsible for the review and update of the program quality plans.
  • Proficiency in the English language is mandatory. 
Read more
vyaparApps

at vyaparApps

5 recruiters
Aditi Muskan
Posted by Aditi Muskan
Bengaluru (Bangalore)
1 - 3 yrs
₹1.5L - ₹3.5L / yr
Quality audit
Quality management
Quality improvement
Quality inspection
Call audit
What is Vyapar?

Vyapar is a business accounting software (android and windows) that simplifies the process of
managing a business for millions of Indian MSMEs. The software allows users to create business transactions, share them with their customers, manage their inventory, keep track of their receivable/payable and manage end-to-end taxation.

Who uses Vyapar?

Vyapar is used by almost every type of business in India, be it retailers, distributors, Wholesalers, Manufacturers or Service Professionals. The horizontal approach towards building Vyapar allows every business to fit it into our Use case and manage it efficiently. From a small garage service center to a multi-outlet grocery store, Vyapar is
built for and used by almost the entire breadth of business types in India. As far as numbers go, Vyapar has been installed by almost 1 crore businessmen across the country

What is the role about?
Job Description:
 Conduct regular Call audits for the Agents.
 Create quality measurements to track improvement in Agents.
 Execute quality improvement activities.
 Adhere to support quality and standards.
 Ensure Services meet customer expectations and demand
 Reports creation and documenting agent’s performance.
 Work closely with the team to improve calling standards.

Education and Experience
 Min- 12th Pass
 Proficient in relevant computer applications
 Required language proficiency, especially Hindi and English
 Good Communication

Key Competencies and Skills
 Strong problem-solving abilities in technical and accounting basics.
 Patience/ Soft Skills
 Diligence
 Problem analysis and problem-solving
 Team player with the ability to work with minimal supervision
Read more
Bengaluru (Bangalore)
3 - 6 yrs
₹20L - ₹30L / yr
Information security
ISO/IEC 27001:2005
Incident management
Systems Development Life Cycle (SDLC)
Acess Management
+1 more

What are we looking for?

An enthusiastic individual with the following skills. Please do not hesitate to apply if you do not match all of it. We are open to promising candidates who are passionate about their work and are team players.

Key Responsibilities & expectations from the candidate 

  • Must have strong experience in Information Security Management system(ISMS), creation of policy, procedures and implementation.
  • Operates as a key contributor to the RFP, Third-Party Risk assessment, cloud security assessment etc.
  • Lead the strategic and tactical development of information security framework, risk management and new compliance initiatives
  • Subject matter expertise in ISO 27001, SOC2, CCPA, CPRA, GDPR, PCI DSS and HIPAA.
  • Must have a strong experience in the documentation process and reviewing MSA, SCC, SLA & DPA.
  • Good knowledge of BCP/DR, Incident response, VA/PT and Audit methodologies of various compliance frameworks.
  • Good knowledge of Access management, Network, Application Security, Encryption, Backup, Physical Security, ISMS Training & Awareness etc..
  • Ability to deal with the customers and vendors on Security and privacy matters.
  • Knowledge of Core IT processes, SDLC, network infrastructure will be useful.

Personal Attributes

  • Good written, oral, and interpersonal communication skills.
  • Ability to conduct research into IT security issues
  • Ability to present ideas in business-friendly and user-friendly language.
  • Ability to effectively prioritize and execute tasks in a high-pressure environment.
  • Highly self-motivated and hardworking.

Qualification and certification 

  • Bachelor’s/master's degree in Security, Computer Science, Management Information Systems, Engineering or related field.
  • Should be at least ISO 27001 lead auditor or lead implementer. 
  • 3+ years of related work experience in information security governance, risk and compliance (GRC) or relevant compliance roles in the SaaS industry.

What can you look for?

A wholesome opportunity in a fast-paced environment that will enable you to juggle between concepts, yet maintain the quality of content, interact, and share your ideas and have loads of learning while at work. Work with a team of highly talented young professionals and enjoy the benefits of being at Xoxoday.

We are

Xoxoday is a rapidly growing fintech SaaS firm that propels business growth while focusing on human motivation. Backed by Giift and Apis Partners Growth Fund II, Xoxoday offers a suite of three products - Plum, Empuls, and Compass. Xoxoday works with more than 2000 clients across 10+ countries and over 2.5 million users. Headquartered in Bengaluru, Xoxoday is a 300+ strong team with four global offices in San Francisco, Dublin, Singapore, New Delhi.

Way forward

We look forward to connecting with you. As you may take time to review this opportunity, we will wait for a reasonable time of around 3-5 days before we screen the collected applications and start lining up job discussions with the hiring manager. We however assure you that we will attempt to maintain a reasonable time window for successfully closing this requirement. The candidates will be kept informed and updated on the feedback and application status.

Read more
Net connect
Bengaluru (Bangalore), Pune, Mumbai, Delhi
3 - 8 yrs
₹5L - ₹15L / yr
Cyber Security
IT security
Risk assessment
Information security
ISO/IEC 27001:2005
+2 more

Qualifications & Responsibilities

 

Year of Experience : 3- 8 yrs

 

Location : Bangalore, Delhi, Mumbai, Pune

 

Work on ISO 27001 & NIST based Information Security Management System implementation and sustenance.

-          Responsible for SOX (IT Security Controls) and track the monthly/quarterly/annual control reports and drive effectiveness of SOX controls.

-          Work on Business Continuity Planning, IT Disaster Recovery as per ISO27001 & NIST requirements

-          Assess information security posture, identify the gaps/risks in the existing environment and develop solutions to mitigate the identified gaps/risk

-          Conduct Information Systems audits covering IT infrastructure assets

-          Working knowledge in security domains such as: security governance policies and procedures, risk management, compliance, access control, network security, security architecture, security incident response, disaster recovery, business continuity management, privacy and data protection

-          Experience in leveraging industry standards and frameworks such as ISO/IEC 27001, NIST CSF/800-171, etc.

-          Possesses certifications such as ISO27001 LA. CISSP, CISA certification- preferred

 

Why NCG?

 

WHO WE ARE DRIVES WHAT WE DO!

 

We Don't build the organization; we create an everlasting family. Our people express a sense of winning together when times are good and sticking together when times are tough.

 

Are you a Doer or Achiever?

 

Well, at NCG, our doors are Open for Doers and Achievers alike. We are a Cult where we create, innovate, learn and Contribute in a comfortable, transparent, and fair environment.

 

Joining NCG means contributing to a shared ambition for reliable work culture, tackling extraordinary technological challenges in multicultural teams, preserving your work/life balance, and more!

Read more
Jaipur
3 - 6 yrs
₹3L - ₹5L / yr
Regulatory affairs
Compliance
food safety
FSSAI
HACCP
+2 more
Are you keen on building your career with an established brand and taking over the responsibility of achieving more with the company, then this role is for you.

Pioneer Foods Pvt Ltd is a Food manufacturing and exporting company that specialises in traditional snacks without compromising on the health factor. Their range of cereal based nutritional ready-to-eat snack packs are "Enriched with goodness". Their products are available across India, Middle East and North America, in stores and through ecommerce websites.

The company believes in focusing on providing tasty, roasted, contemporary flavoured and highly nutritious ingredients like Quinoa , Chia , Flaxseeds , Sunflower seeds, Oats, Fenugreek etc. with an Indian twist to the health-conscious current and future generations.
 
As a Senior Executive - Regulatory Affairs, you will conduct regular internal audit with QC and production teams; analyses, report and implement corrective and preventive action regularly basis these audits.
 
What you will do:
  • Ensuring proper documentation, updates, implementation and renewals of all statutory and regulatory compliances including but not limited to Legal Metrology/ FSSAI / HACCP / ISO / BRCGS / USFDA etc.
  • Updating self and team with knowledge / Experience with EU, UK, USA, Australia, Canada regulations
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Keeping a check on label content and leaflets as per regulatory norms (Label proofing & Artwork)

 

What you need to have:
  • Must know HACCP, FSSAI , ISO, BRCGS,USFDA standards, FSMA Act, rules & regulations, statutory compliances etc.
  • Must have in-depth knowledge of Indian / global labelling rules and regulations
  • Minimum 3-5 years of experience in Quality Regulatory in the F&B industry (preferably ready to eat snack segment)
  • Graduation in food technology Post-graduation not necessary.
  • Good knowledge of Microsoft Office
  • Proficient in oral and written English and Hindi
Read more
Alke Research private limited
ALBEN Sigamani
Posted by ALBEN Sigamani
Remote, Bengaluru (Bangalore)
1 - 5 yrs
₹4L - ₹9L / yr
Good Clinical Practice
Clinical Research
Pharmacology
Regulatory affairs
CLINICAL TRIALS
+1 more
A full time Clinical Research Associate works on clinical trials and other exploratory research projects subcontracted by Alke Research Pvt Ltd. The job requires vibrant and hardworking individuals with a zeal to build a career in the clinical research industry.
Carry out independent site feasibility and selections 
Help with site initiation and trial activation
Carry out independent site monitoring; online and offline
Help with preparing Serious Adverse Event report filing with the regulatory
Provide assitance to site in protocol related queries, ICH GCP Training for site personnel
Be a liasion between the sponsor, investigator and CRO
Support the site prepare and face regulatory audit / site inspections
Read more
UK based out company
Agency job
via Theexceptionals by Poonam Kumari
Mumbai
3 - 7 yrs
₹6L - ₹8L / yr
ISO/IEC 27001:2005
ISO/IEC 27000-series
ISAE 3402
ISMS

B. Aims & Goals:

You are required to work with all departments at Pelican to implement, enhance and improve ISMS, GDPR and ISAE 3402 processes. You will also be closely working with external auditor as well as top management for status and reporting.

 

C. Key Responsibilities:

Your primary responsibilities include:  Assist in audit planning, including the identification of processes for audit review.   Execute internal audit assignments for all locations in India, US, UK and NL. Review the effectiveness of the controls.   Identify and document audit issues and opportunities for improvement.  Prepare the audit report for internal audit assignments and discuss audit findings with senior management.   Monitor and maintain the CAPA program. Assist with follow up corrective actions and oversee timely completion.  Facilitate independent audit engagements on behalf of the company.  Assist to develop and implement process improvements and best practices across the business unit. Review policies and procedures for all areas of the business.  Develop new policies and procedures as directed or required, to improve and to collect and analyse data for review with internal stakeholders.  Take responsibility for the management and execution of internal audit assignments, production of audit reports and management of follow up actions  Involved with working across all areas of the business to ensure that processes are documented and compliant to the company’s requirements.

 

D. Experience level & Qualification:

a. Experience Level  4 to 5 yrs

 

b. Educational background  B.E / B.Sc / B.com / Bachelor’s Degree  Holds ISO 27001:2013 Certification

 

E. Essential Skills:  Should have participated in ISMS (ISO 27001:2013) implementation and certification process.

Read more
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