Quality Assurance Manager

Position: Senior QA – Specialist / QA ManagerLocation: Gandhinagar (GNR)Job Overview:We are looking for a highly skilled and experienced Quality Assurance (QA) professional to leadand maintain robust quality systems, ensuring compliance with both regulatory requirementsand customer standards. This role is critical in driving continuous improvement and auditreadiness across the organization.The ideal candidate will have a strong background in QA practices within the pharmaceutical orequipment manufacturing sector, with proven experience in documentation, audits, andcompliance.Key Responsibilities:1. Quality Systems Management• Oversee and maintain site-wide quality systems and the complete lifecycle of GMPdocumentation.• Manage SOP implementation and control, including the issuance, retrieval, andarchiving of logbooks and controlled documents.2. Batch & Product Quality Assurance• Review Batch Manufacturing Records (BMR), master documents, and ensure adherenceto production quality standards.• Issue and manage Certificates of Quality (COQ) and Certificates of Analysis (COA) for allfinished product batches.3. Audit & Regulatory Compliance• Lead preparations for internal, customer, and regulatory audits to ensure complianceand audit readiness.• Manage Corrective and Preventive Actions (CAPA), track progress, and verifyeffectiveness.4. Vendor and Training Oversight• Conduct vendor audits and maintain supplier quality assurance.• Develop and deliver QA-related training programs across departments to supportregulatory compliance and quality awareness.5. Documentation & Reporting• Compile and analyze quality metrics for management review.• Manage and resolve customer complaints, internal deviations, and non-conformancesthrough thorough root cause analysis and CAPA.Qualifications:• Graduate/Postgraduate in Science (Chemistry, Biology, Microbiology, Biotechnology) orB.Pharm/M.Pharma.• 8 – 10 years of experience in QA, preferably in the pharmaceutical or equipmentmanufacturing sectors.Key Skills & Competencies:• Strong proficiency in SOP writing, document control, and GMP practices.• In-depth knowledge of audit handling, CAPA processes, and root cause analysis tools.• Excellent communication skills and ability to collaborate across functions.• Strong organizational skills with attention to detail and ability to manage multiplepriorities.• Effective leadership and team management abilities.• Professional demeanor with a solution-oriented mindset.

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