Quality assurance manager

Position: Senior QA – Specialist / QA Manager
Location: 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 Management
• Oversee 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 Assurance
• Review 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 Compliance
• Lead 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 Oversight
• Conduct 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 & Reporting
• Compile 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. Pharma.
• 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.