AGM/GM - Quality

Job Summary Responsibilities

• Site Quality Leadership: To establish and maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
• To represent the organization as the Quality Management Representative during internal, external, and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
• Quality Management System (QMS) Ownership: To ensure compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
• To ensure cGMP/GLP/GDP/GEP followed by all personnel.
• To manage batch release processes, ensuring timely review and disposition in alignment with GMP requirements.
• To manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
• To Lead continuous improvement initiatives to enhance the Quality Management System (QMS) and drive operational excellence.
• Audit Exposure: eu-gmp, us-fda, WHO, pic/s, anvisa
• Batch Release and Product Quality Oversight: To ensure timely review and approval of Batch Manufacturing Records, Quality Control (QC) reports, and Certificates of Analysis (COA).
• To execute QA release for commercial and validation batches, including product quality review and compliance verification.
• Training and Development: To establish and led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
• To build quality culture across the site through continuous learning initiatives and behaviour-based quality systems.
• Cross-functional Collaboration: To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, and Corporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
• Risk Management (QRM); Continuous Improvement: To Lead Quality Risk Management (QRM) activities, including risk assessments and mitigation planning to proactively identify and address quality and compliance risks.
• Qualifications Validations: To ensure effective coordination with validation teams for timely execution of equipment qualifications, re-qualifications, and periodic reviews of OSD manufacturing equipments and Injection manufacturing equipment like Autoclave, Tunnel, Vial washing machine, Filling machine, Lyophilizer, Isolators and utilities like HVAC systems, Nitrogen, compressed air, water system, pure steam.
• To oversee Process Validation, Cleaning Validation activities and Aseptic Process simulation compliance to ensure alignment with current regulatory expectations and cGMP standards.
• Audits and Compliance: To lead and actively participate in external regulatory audits and customer audits, serving as a key point of contact for quality and compliance matters.
• To demonstrate strong audit-facing capabilities with a proven track record in managing regulatory and customer audits, ensuring timely and effective closure of observations through robust CAPA implementation.
• In-Process Quality Systems cGMP Compliance: To be accountable for in-process Quality Assurance (IPQA) activities across Liquid Injectable, Lyophilized Injectable, and Solid Oral Dosage manufacturing and packing areas.
• To ensure adherence to current Good Manufacturing Practices (cGMP) by proactively monitoring operations and resolving day-to-day quality and compliance issues in real time.
• Documentation, Data Control Regulatory Compliance: To ensure timely review and approval of key quality documents including Annual Product Quality Reviews (APQRs), Continued Process Verification (CPV) reports, and implementation of CAPAs where required.
• To oversee accurate stability monitoring programs in compliance with ICH guidelines and customer-specific requirements.

Required Skills

• Logical thinking
• Organizing

Required Qualification Key Skills

• Audit Exposure
• Site Quality Leadership