5+ QMS Jobs in India

Job Summary:

We are seeking an experienced and detail-oriented Senior Manager – Quality Assurance & Regulatory Affairs to lead and oversee all quality and regulatory functions within our company.

This role requires in-depth knowledge of industry standards, regulatory frameworks, and manufacturing best practices, ensuring that products meet safety, efficacy, and compliance requirements across global markets.

Key Responsibilities:

Quality Assurance (QA):

• Develop, implement, and manage the Quality Management System (QMS) in compliance with ISO, GMP, and other applicable standards.

• Oversee quality audits (internal and external) and ensure timely closure of non-conformities.

• Lead QA initiatives throughout the product lifecycle—from R&D to production to market release.

• Review and approve SOPs, batch records, and change control documentation.

• Ensure quality assurance processes align with manufacturing and packaging operations to maintain product integrity.

• Monitor and manage deviations, CAPAs (Corrective and Preventive Actions), and risk assessments.

• Coordinate with production and R&D teams for validation and stability studies. Regulatory Affairs (RA):

• Ensure product compliance with national and international regulatory standards (e.g., FDA, EU Cosmetics Regulation, BIS, CDSCO, ASEAN, etc.).

• Prepare and submit dossiers for product registration and licensing in various geographies.

• Maintain regulatory intelligence and advise the business on upcoming regulatory changes affecting products.

• Handle labelling compliance, ingredient review, and claims substantiation as per regulatory norms.

• Act as the regulatory liaison with government bodies, external auditors, and certification agencies.

• Maintain all necessary documentation and technical files for regulatory audits and inspections. Team Leadership & Cross-Functional Collaboration:

• Lead and mentor the QA & RA teams, driving continuous improvement and knowledge sharing.

• Collaborate with R&D, Manufacturing, Marketing, and Legal teams to ensure regulatory and quality alignment at all stages of product development and launch.

• Support expansion by facilitating regulatory approval processes in target markets.

Required Qualifications & Skills:

• Bachelor’s or Master’s degree in Pharmacy, Cosmetic Technology, Chemistry, or related field.

• 10–15 years of experience in the skincare/cosmetic industry, with a strong background in QA and Regulatory Affairs.

• In-depth understanding of cosmetic regulations (India, EU, US, Middle East, Southeast Asia, etc.).

• Strong leadership, organizational, and communication skills.

• Hands-on experience with regulatory submissions, audits, and compliance strategy.

• Detail-oriented with the ability to manage multiple projects and deadlines.

Preferred:

• Experience working with natural/organic skincare & cosmetic product lines.

• Certifications in ISO 22716 (GMP for cosmetics), ISO 9001, or similar quality systems.

• Familiarity with product safety assessments, microbiological testing, and toxicology reports

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Skills: C++, QT, UI, TCP/IP, HTTP/HTTPS, Networking Protocols

Branch: Computer Science (B.E/B.tech)

Location: Bangalore (Work from Office)

Experience- 1-5yrs

At Prolifics, we are currently implementing multiple solutions on PCQA Manager for our development centre in India. This position would be based out of Hyderabad location and is a permanent position.

If you are looking for a high growth company with rock-solid stability, if you thrive in the energetic atmosphere of high profile projects, we want to talk to you today! Let’s connect and explore possibilities of having you onboard the Prolifics team!

Job Title:                    Manager - PCQA

Primary skills:                7+ years of experience

Location:                    Hyderabad

Educational Qualification:      B.Tech/BE/M.Tech/MCA/M.Sc

JD:

 The PCQA Manager is a key role to support the process improvement (CMMI V2.0) initiative that will help assess the quality of the software delivered by a growing Software Development Company to its customers. This role will be part of the PCQA team, which helps the organization sustain SEI CMMI DEV Level 5, upgrade to CMMI V2.0 and support other methodology related initiatives.

• Lead the PCQA team and be flexible to take up assignments within the team such as Coaching, Auditing, implementation, process improvement projects, QMS process improvements, agile practices implementation etc.
• Mentor the team in the development and implementation of QMS aligning to CMMI V2.0 within the organization across geographies
• Identify improvements opportunities in the existing policies, processes, procedures, templates and metrics for the organization
• Define and utilize metrics and reports to manage quality efforts
• Prepare and conduct quality assurance product reviews and prepare projects teams ready for process audits according to the audit plan
• Sound understanding of Process Frameworks/Methodologies like CMMI-Dev, SVC, AGILE SCRUM etc.
• Good understanding of various software development life cycles
• Ability to influence and drive delivery with global senior management
• Attention to detail while keeping a global perspective, willing to deep-dive for data analysis
• Good communication and interpersonal skills to interact with global stakeholders
• Very good understanding of Information security concepts and implementation experience of ISO 27001 and other security standards is a value add

About us:

Prolifics Corporation Limited is a Global Technology Solutions Provider with presence across North America (USA and Canada), Europe (UK and Germany), Middle East & Asia. In India, we have off shore development centers: 3 in Hyderabad & 1 in Pune.

For more than 40 years, Prolifics has transformed enterprises of all sizes including over 100 Fortune 1000 companies by solving their complex IT challenges. Our clients include Fortune 50 and Fortune 100 companies across a broad range of industries including Financial Services, Insurance, Government, Healthcare, Telecommunications, Manufacturing and Retail. We rank consistently in Dream Companies to Work For and Dream Employer of the Year ranking from World HRD Congress, ranked 7 in 2019.

We encourage you to visit us on www.prolifics.com or follow us on Twitter, LinkedIn, Facebook, Youtube and other social media to know more about us.

• Working closely with the external auditors to achieve common goals
• Conducting Enabling Service Audit (HR, Admin, IT) once in 6 months for the verification of ISMS & QMS Standards
• Performing ISMS and Internal Audit
• Being part of the external Audits (ISMS, QMS & CMMI)
• Managing of implementation of ISMS

Desired Candidate Profile

• Strong communication and team building skills with proficiency at grasping new technical concepts quickly and utilizing the same in a productive manner
• Experience in ISO27001, Internal Audits, CMMI