Associate Manager QMS

1. Role Purpose
The QMS Section in Charge shall be responsible for managing and maintaining the site Quality Management System to ensure compliance with GMP, GDP, ICH Q7, ISO requirements, customer expectations, and applicable regulatory standards. The role is accountable for effective control of QMS records, documentation systems, CAPA implementation, audit readiness, validation/qualification review, and continual improvement of quality systems.
2. Key Responsibilities
Manage QMS activities including deviations, incidents, change controls, CAPA, OOS/OOT, complaints, recalls, returns, market complaints, and quality risk management.
Ensure preparation, review, approval, issuance, revision, archival, retrieval, and destruction of GMP documents, SOPs, formats, quality manuals, and controlled copies.
Review and monitor QMS records in TrackWise/eQMS/DMS and ensure timely closure of actions with appropriate investigation, root cause, impact assessment, CAPA, and effectiveness checks.
Prepare and review QMS trend reports, quality system review reports, management review inputs, and audit compliance reports.
Review validation/qualification protocols and reports for equipment, utilities, facilities, instruments, manufacturing processes, cleaning processes, and computerized systems.
Participate in internal, customer, vendor, and regulatory audits; coordinate audit responses and ensure timely closure of observations and CAPA.
Conduct plant rounds to verify GMP, GDP, data integrity, hygiene, safety, and procedural compliance.
Support finished goods release, dispatch documentation review, BPCR/ECR/PCCR review, IPQA/data review activities, calibration review, vendor qualification, reserve sample management, and EHS compliance.
Coordinate with Production, QC, Engineering, Warehouse, EHS, Regulatory Affairs, and other departments for effective implementation of quality systems.
Perform delegated responsibilities in the absence of senior QA personnel and ensure proper delegation of work during own absence.
3. Required Skills and Competencies
Sound knowledge of GMP, GDP, ICH Q7, ISO, data integrity, ALCOA+, and pharmaceutical/API quality system requirements.
Strong understanding of QMS elements, documentation control, investigation handling, CAPA, change management, audit management, and quality risk management.
Working knowledge of TrackWise/eQMS, DMS, CSV, validation/qualification review, BPCR/ECR/PCCR review, and electronic documentation systems.
Ability to assess root cause, product/process impact, compliance risk, and CAPA effectiveness.
Good technical writing, report preparation, communication, coordination, and presentation skills.
Leadership ability to guide team members, follow up cross-functionally, prioritize work, and maintain audit readiness.
4. Education
B.Sc./M.Sc. in Chemistry, Pharmaceutical Chemistry, Microbiology, Biotechnology, or related life science discipline; or B.Pharm/M.Pharm.
5. Work Experience
7–12 years of relevant experience in Quality Assurance/QMS in pharmaceutical, API, chemical, or other regulated manufacturing industry.

Work arrangement
No