Officer / Executive / Assistant Manager - Quality Assurance (IVD)

About the Role

Meril Diagnostic Pvt. Ltd., a renowned organization in the In Vitro Diagnostics (IVD) industry located in Vapi, Gujarat, is seeking dedicated professionals for Quality Assurance positions at various levels including Officer, Executive, and Assistant Manager. Candidates will contribute significantly to uphold and enhance quality compliance aligned with global standards, ensuring innovative diagnostic solutions positively impact healthcare worldwide.

Key Responsibilities

Officer / Executive:

• Guarantee adherence to current Good Manufacturing Practices (cGMP), ISO 13485, and internal Standard Operating Procedures throughout manufacturing processes.
• Conduct In-Process Quality Assurance (IPQA), manage line clearance tasks, and review batch manufacturing records.
• Oversee manufacturing activities including dispensing, packaging, and maintain environmental quality to assure product standards.
• Develop and maintain Quality Management System documentation such as SOPs, Change Controls, Deviation reports, Incident reports, Out-of-Specification/Out-of-Trend (OOS/OOT) documentation, and Yield Deviations.
• Verify batch manufacturing documentation, analytical data, and quality records.
• Assist in validation and qualification procedures.
• Perform self-audits and enforce Good Documentation Practices (GDP).
• Collaborate effectively with Production, Quality Control, Regulatory Affairs, and Packaging to ensure efficient production outcomes.

Assistant Manager:

• Lead all Plant QA functions including IPQA, QMS management, vendor oversight, complaint resolution, CAPA implementation, Change Control, Controlled Document Change Requests (CDCR), process validation, and line clearance.
• Ensure compliance with international standards including ISO13485, WHO regulations, IVDR, and cGMP guidelines.
• Approve quality documentation such as SOPs, batch records, and validation protocols.
• Manage handling of customer complaints, deviations, investigations, corrective actions, recalls, and non-conformance issues.
• Conduct internal audits, vendor audits/qualifications, and drive continuous quality improvements.
• Implement process mapping, trend evaluations, risk assessments, and other initiatives to enhance quality systems.
• Coordinate quality planning functions with cross-department teams including Production, QC, Regulatory Affairs, Marketing, and Packaging Development.
• Train and mentor QA team members promoting a culture of quality and regulatory compliance.

Qualifications and Skills

• Educational background with a Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biomedical Engineering, or related fields.
• Proven experience in Quality Assurance within the Medical Device or IVD sector is essential.
• Comprehensive knowledge of ISO 13485, WHO guidelines, EU IVDR, cGMP standards, and Quality Management Systems.
• Practical expertise in IPQA, process validation, vendor management, complaint handling, CAPA, change control, audits, documentation maintenance.
• Strong problem-solving, analytical reasoning, meticulous documentation skills, and effective communication abilities.

Why Work with Meril?

• Opportunity to collaborate with a globally acknowledged Medical Device and IVD leader.
• Experience exposure to international regulatory standards and quality systems.
• Engagement in innovative diagnostic technology projects.
• A workplace that fosters learning, collaboration, and career growth.