Quality Assurance Manager

7 days ago

Gandhinagar, Gujarat, India Gopani Product Systems Pvt Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Position: Senior QA – Specialist / QA ManagerLocation: Gandhinagar (GNR)Job Overview:We are looking for a highly skilled and experienced Quality Assurance (QA) professional to lead and maintain robust quality systems, ensuring compliance with both regulatory requirements and customer standards. This role is critical in driving continuous improvement and audit readiness across the organization. The ideal candidate will have a strong background in QA practices within the pharmaceutical or equipment manufacturing sector, with proven experience in documentation, audits, and compliance.

Key Responsibilities:1. Quality Systems ManagementOversee and maintain site-wide quality systems and the complete lifecycle of GMP documentation. Manage SOP implementation and control, including the issuance, retrieval, and archiving of logbooks and controlled documents.2.

Batch & Product Quality AssuranceReview Batch Manufacturing Records (BMR), master documents, and ensure adherence to production quality standards. Issue and manage Certificates of Quality (COQ) and Certificates of Analysis (COA) for all finished product batches.3. Audit & Regulatory ComplianceLead preparations for internal, customer, and regulatory audits to ensure compliance and audit readiness.

Manage Corrective and Preventive Actions (CAPA), track progress, and verify effectiveness.4. Vendor and Training OversightConduct vendor audits and maintain supplier quality assurance. Develop and deliver QA-related training programs across departments to support regulatory compliance and quality awareness.5.

Documentation & ReportingCompile and analyze quality metrics for management review. Manage and resolve customer complaints, internal deviations, and non-conformances through thorough root cause analysis and CAPA.Qualifications:Graduate/Postgraduate in Science (Chemistry, Biology, Microbiology, Biotechnology) or B.Pharm/M.Pharm.8–10 years of experience in QA, preferably in the pharmaceutical or equipment manufacturing 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 multiple priorities.

Effective leadership and team management abilities. Professional demeanor with a solution-oriented mindset.

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