Job Summary
We are seeking an experienced Sr. Executive – QA (RA & NPD) to manage quality assurance activities, ensure regulatory compliance, and support new product development. The ideal candidate will be responsible for maintaining quality systems, preparing regulatory documentation, coordinating product registrations, validating processes, and ensuring products meet applicable national and international quality standards.
Key Responsibilities Quality Assurance (QA)
- Ensure compliance with GMP, ISO, and company quality standards.
- Develop, review, and maintain SOPs, specifications, protocols, and quality documents.
- Conduct internal quality audits and monitor CAPA implementation.
- Handle deviations, change controls, non-conformances, and customer complaints.
- Review batch manufacturing records and quality documentation.
- Coordinate validation and qualification activities (Process, Cleaning, Equipment).
- Support supplier qualification and vendor audits.
- Monitor quality KPIs and prepare periodic quality reports.
Regulatory Affairs (RA)
- Prepare and maintain regulatory dossiers and technical documentation.
- Coordinate product registrations, renewals, and regulatory submissions.
- Ensure compliance with applicable regulatory guidelines and standards.
- Monitor changes in regulatory requirements and implement necessary updates.
- Respond to regulatory authority queries and customer documentation requests.
- Maintain product licenses, certifications, and regulatory records.
New Product Development (NPD)
- Coordinate with R&D, Production, Purchase, and Marketing teams for new product development.
- Prepare product specifications, quality plans, and validation protocols.
- Conduct risk assessments and feasibility evaluations.
- Support product trials, pilot batches, and technology transfers.
- Ensure timely commercialization of new products while maintaining quality compliance.
- Prepare product documentation for product launch.
Required Qualifications
- Bachelor's or Master's Degree in Pharmacy, Chemistry, Biotechnology, Microbiology, Life Sciences, or a related field.
- Additional certification in Quality Management or Regulatory Affairs is an added advantage.
Experience
- 3–5 years of relevant experience in QA, Regulatory Affairs, and/or New Product Development.
- Experience in Pharmaceutical, Medical Device, Healthcare, Chemical, or Manufacturing industries is preferred.
Pay: ₹45,000.00 - ₹50,000.00 per month
Work Location: In person
