Quality Assurance Specialist (Ludhiana)

Quality Assurance Specialist (Ludhiana)

05 Nov
|
Cook N Klean
|
Ludhiana

05 Nov

Cook N Klean

Ludhiana

Job Description
– 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

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