6+ Regulatory affairs Jobs in India
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Job Purpose:
The role entails the responsibility to be a part of IT Governance and Compliance Team of the bank and would be working towards GRC control function: Compliance & Regulatory reporting viz Cyber KRI, TRANCHE, ICAAP etc.
Roles & Responsibilities:
- Custodian of IT governance and IT process governance framework.
- Handling of Regulatory audits and submissions.
- To understand Indents from regulators, collated, review the data and timely submission.
- Responsible for IT policy creation, review, update, awareness, and monitoring.
- Administration of key IT processes: E.g., incident management, policy exception management
- Will be reporting to Lead IT Governance.
- Identify improvements and breakdowns in IT governance elements with significant business impact.
- Create and maintain library of governance artifacts and other supporting documentation.
- Proactively identify and manage risks/issues, ensure proper visibility and communication occur to senior management.
- Ensures compliance with all policies and procedures in the execution of technology projects.
- Provide guidance and trainings to Project team members in the field regarding IT governance.
- Capture and share best- practice knowledge amongst the team.
- Create an environment that promotes collaborative learning and collective ownership of responsibilities.
- Strong analytical and problem-solving skills. Excellent communication and interpersonal abilities.
- Ability to work independently and collaborate effectively in a team environment.
Education Qualification (Fulltime):
Certified Chartered Accountant (CA)
REQUIRE QUALITY ASSURANCE EXECUTIVE
EDUCATION – GRADUATE- BSC/BPHARMA
SKILLS- QA, TESTING KNOWLEDGE, REGULATORY AFFAIRS,
EXPERIENCE – MIN 3 YEARS IN PHARMA
SALARY – UPTO 35K
at Synapsica Technologies Pvt Ltd
Job Title: QA Associate
Job Description:
- Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
- Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
- 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.
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
Pioneering Healthy Snacks Company
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.
- 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
#1 global pharma healthcare in over-the-counter medicines
- Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
- Support in ensuring transition activity is planned and executed to schedule, budget and scope
- Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
- Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
- Keep stakeholders involved in transition process and update them with the progress and roadblocks
- Promote awareness of transition planning and support processes within the GCC
- Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
- Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC
Skills:
- Proven knowledge of service transition methodology, tools and templates through experience or qualifications
- The ability to identify, escalate and manage project risks with the Transition Lead
- 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
- Good exposure in previous roles to multi-cultural, transversal functions
- Pharma background with experience across the systems development life cycle with experience in different project phases
- Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing