FDC India Hiring QA Validation & Qualification

A leading pharmaceutical company is expanding its team! We specialize in manufacturing Ophthalmics, Oral Liquids, Oral Powders, and Topical Powders, with each production section housed in a dedicated facility. Our Ophthalmics section features three State-of-the-Art Blow-Fill-Seal (BFS) machines, catering to Regulated and Semi-regulated markets.

Post : Executive / Sr. Executive (QA) Validation & Qualification

Qualification : B. Pharmacy / M.Pharmacy
Experience : 4 to 7 Years experience
Department : (QA) Validation & Qualification
Location : Sinnar, Nashik

Job Description
1. To prepare the Document: Validation Master Plan, Quality Manual, Site Master File.
2. Prepare, review, and execute DQ, IQ, OQ, and PQ protocols and reports.
3. Perform qualification of manufacturing equipment, utilities, HVAC systems, purified water (PW), pure steam generators (PSG), compressed air, nitrogen, and clean room facilities.
4. Coordinate qualification activities with Engineering, Production, Quality Control, and external vendors.
5. Conduct risk assessments (FMEA/Risk-Based Validation) for qualification and validation activities.
6. Evaluate validation results and recommend corrective and preventive actions where required.
7. Execute Process Validation, Cleaning Validation, Hold Time Studies, and Utility Validation.
8. Review P&IDs, Functional Specifications (FS/FDS), Design Qualification documents, and engineering drawings.
9. Support internal audit / Participate in investigations related to validation deviations.
10. Coordinate FAT, SAT, commissioning, qualification, and validation activities for new projects.
11. QMS Document Handling: Handling of Deviation, change control, CAPA, EM, water system data trending, Validation planner preparation.
12. Computer System Validation, Cleaning Validation, Process Validation.

Application Information
• Those who have relevant experience in the above profile only, those candidates can apply for this opening.
• Interested candidates, please share your updated CV with the following details :
o Total Number of Experience
o Current Designation
o Current CTC
o Expected CTC
o Notice Period