Job Location: Chennai
Role Description:
We are seeking a Quality Assurance (QA) Manager to oversee and ensure compliance with quality
standards, regulatory requirements, and Good Manufacturing Practices (GMP). The role requires
strong expertise in Quality Management Systems (QMS), audits, and process improvements.
Designation: QA Manager
Department: Quality Assurance
Experience: Minimum 7 years in Medical Device/Pharma/Life Sciences Industry
Regulatory Experience: Minimum 3-5 years in ISO 13485, MDSAP, US FDA, GMP Compliance
Industry/Background: Medical Device / Pharma / Lifesciences Industry
Qualification: B. Pharm / M. Pharm / M.Sc. Life Science / B.Tech Biotechnology / Related Field
Employment Status: Permanent
Workplace Type: On-site
Minimum Requirements:
- Strong knowledge of ISO 13485, QMS, MDSAP, and US FDA guidelines.
- Experience in conducting and facing regulatory audits (MDSAP, FDA, ISO).
- Expertise in quality documentation, deviation handling, and CAPA.
- Experience in risk management, validation, and qualification processes.
- Ability to lead and coordinate internal and external audits.
- Experience in handling change control, non-conformances, and product recalls.
- Strong communication and leadership skills.
Roles and Responsibilities:
- Develop and implement Quality Management Systems (QMS) as per regulatory guidelines.
- Ensure compliance with GMP, US FDA, MDSAP, and ISO 13485.
- Conduct and lead internal audits, external audits, and supplier audits.
- Oversee CAPA, deviations, complaints, and non-conformances.
- Ensure proper documentation and timely submission of regulatory reports.
- Provide training and guidance to teams on quality procedures.
- Collaborate with cross-functional teams to ensure product quality and compliance.
- Support regulatory filings and post-approval compliance activities.|
Send your resume to: [email protected]
