Associate Manager QMS

IOL Chemicals and Pharmaceuticals Limited; Barnala; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

IOL Chemicals and Pharmaceuticals Limited in India seeks a QMS Section in Charge to maintain the site Quality Management System, ensure GMP/GDP/ICH Q7 compliance, and drive continual improvement. You will manage records, CAPA, audits, validation reviews, and cross‑functional coordination.

Ideal candidates have 7–12 years in QA/QMS in regulated manufacturing, with strong documentation and leadership skills. This is an on‑site role based in Punjab/Barnala.

Qualifications

• Proven experience in GMP/GDP/ICH Q7 aligned quality systems.
• Strong knowledge of QMS and documentation control.
• Experience with CAPA, audits, and data integrity.
• Experience in regulated manufacturing and quality systems.

Responsibilities

• Manage deviations, incidents, CAPA, and change controls.
• Oversee GMP document review, archiving and destruction.
• Monitor QMS records and ensure timely closures.
• Prepare quality system review and audit reports.
• Review validation/qualification protocols and reports.
• Coordinate audits with internal and regulatory bodies.
• Conduct plant rounds for GMP and data integrity checks.
• Support release and compliance activities across departments.

Skills

GMP

GDP

ICH Q7

ISO standards

Data integrity

ALCOA+

Education

B.Pharm

M.Pharm

Chemistry/Biotech/related life science

Tools

TrackWise

eQMS

DMS

CSV

Job description

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

1. Manage QMS activities including deviations, incidents, change controls, CAPA, OOS/OOT, complaints, recalls, returns, market complaints, and quality risk management.
2. Ensure preparation, review, approval, issuance, revision, archival, retrieval, and destruction of GMP documents, SOPs, formats, quality manuals, and controlled copies.
3. 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.
4. Prepare and review QMS trend reports, quality system review reports, management review inputs, and audit compliance reports.
5. Review validation/qualification protocols and reports for equipment, utilities, facilities, instruments, manufacturing processes, cleaning processes, and computerized systems.
6. Participate in internal, customer, vendor, and regulatory audits; coordinate audit responses and ensure timely closure of observations and CAPA.
7. Conduct plant rounds to verify GMP, GDP, data integrity, hygiene, safety, and procedural compliance.
8. 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.
9. Coordinate with Production, QC, Engineering, Warehouse, EHS, Regulatory Affairs, and other departments for effective implementation of quality systems.
10. 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.