– 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

📌 Quality Assurance Specialist Ludhiana
🏢 Cook N Klean
📍 Ludhiana