– QA Executive/Manager – Equipment Validation

Position: QA – Equipment Validation

Department: Quality Assurance

Industry: Pharmaceutical – Injectable

Experience: 3–5 years in QA/Validation, preferably in sterile/injectable manufacturing

Job Purpose

Responsible for planning, reviewing, and executing equipment qualification and validation activities to ensure compliance with GMP and regulatory requirements.

Key Responsibilities

- Prepare, review, and approve URS, DQ, IQ, OQ, PQ, and validation protocols/reports.
- Coordinate qualification of manufacturing and utility equipment used in injectable/sterile operations.
- Review validation documents, deviations, change controls, and CAPA related to qualification activities.
- Ensure compliance with GMP, regulatory guidelines, SOPs, and data integrity requirements.
- Coordinate with Engineering, Production, QC,



and QA for qualification and validation activities.
- Support internal, customer, and regulatory audits related to equipment qualification.
- Maintain validation documentation and ensure timely completion of validation schedules.
- Participate in risk assessments and periodic review/requalification activities.

Qualification B.Pharm / M.Pharm / B.Tech / M.Tech or equivalent relevant qualification.

Key Skills

RM Testing, SPEC, COA , Equipment Qualification • IQ/OQ/PQ • URS/DQ • GMP • Validation Documentation • Risk Assessment • Change Control • Deviation/CAPA • Sterile/Injectable Manufacturing • Audit Readiness

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📌 Quality Assurance Specialist (Ludhiana)
🏢 Cook N Klean
📍 Ludhiana