FDC Limited is inviting applications from experienced pharmaceutical professionals for Executive / Senior Executive – QA Validation & Qualification positions at its Sinnar, Nashik facility. Candidates with a B.Pharmacy or M.Pharmacy qualification and 4–7 years of relevant experience in pharmaceutical Quality Assurance, validation, and qualification can apply for this opportunity.
The FDC QA Validation job involves equipment and utility qualification, process and cleaning validation, Computer System Validation (CSV), QMS documentation, risk assessment, and preparation and execution of validation protocols. Candidates should have practical knowledge of regulated pharmaceutical manufacturing environments and validation lifecycle activities.
Professionals currently working in QA Validation, Qualification, Process Validation, Cleaning Validation, CSV, Equipment Qualification, or Utility Validation can consider this FDC Limited career opportunity.
Key Responsibilities
Selected candidates for the FDC QA Validation & Qualification Executive/Sr. Executive position will be responsible for:
- Preparing and maintaining the Validation Master Plan (VMP), Quality Manual, and Site Master File (SMF).
- Preparing, reviewing, and executing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
- Performing qualification of pharmaceutical manufacturing equipment and utilities.
- Handling qualification of HVAC systems, Purified Water (PW), Pure Steam Generators (PSG), compressed air, nitrogen systems, and clean-room facilities.
- Coordinating validation and qualification activities with Engineering, Production, Quality Control, external vendors, and other stakeholders.
- Conducting FMEA and risk-based validation assessments for validation and qualification activities.
- Evaluating validation results and recommending appropriate Corrective and Preventive Actions (CAPA) when required.
- Executing Process Validation, Cleaning Validation, Hold Time Studies, and Utility Validation.
- Reviewing P&IDs, Functional Specifications (FS/FDS), Design Qualification documents, and engineering drawings.
- Supporting internal audits and investigations associated with validation deviations.
- Coordinating Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification, and validation for new projects.
- Handling QMS documentation, including deviations, change controls, CAPA, environmental monitoring data, water-system data trending, and validation planners.
- Supporting Computer System Validation (CSV), Cleaning Validation, and Process Validation activities.
Qualification and Experience
Candidates applying for the FDC QA Validation recruitment should meet the following eligibility criteria:
Educational Qualification: B.Pharmacy or M.Pharmacy.
Experience: 4–7 years of relevant pharmaceutical industry experience.
Candidates should preferably have direct hands-on experience in Quality Assurance Validation & Qualification, including DQ/IQ/OQ/PQ, equipment and utility qualification, process validation, cleaning validation, CSV, QMS documentation, and risk assessment.
FDC has specifically indicated that only candidates with relevant experience in the above profile should apply.
Skills Preferred for FDC QA Validation Jobs
Relevant skills for this position include:
- QA Validation & Qualification
- DQ, IQ, OQ and PQ
- Validation Master Plan
- Equipment Qualification
- Utility Qualification
- Process Validation
- Cleaning Validation
- Computer System Validation (CSV)
- HVAC Qualification
- Water System Qualification
- Risk Assessment / FMEA
- FAT and SAT
- CAPA
- Deviation Management
- Change Control
- QMS Documentation
- Pharmaceutical GMP Compliance
Why Consider This Opportunity?
This FDC Quality Assurance position offers experienced pharmaceutical professionals exposure to a broad validation and qualification portfolio. The role covers manufacturing equipment, critical utilities, clean-room facilities, computerized systems, process validation, cleaning validation, QMS activities, and new-project qualification.
The position may be particularly relevant for B.Pharm and M.Pharm professionals looking to strengthen their careers in pharmaceutical Quality Assurance, validation, qualification, and GMP compliance.
Specific salary, incentives, insurance, and other employee benefits have not been disclosed in the provided recruitment notice and should be confirmed directly with FDC during the recruitment process.
FDC Job Location
The position is based at:
Sinnar, Nashik, Maharashtra, India
Candidates should consider their ability to work at the Sinnar location before applying.
How to Apply for FDC QA Validation Jobs
Interested and eligible candidates can send their updated CV/resume to the email address mentioned in the official recruitment notice:
Email: nijanand.kulkarni@fdcindia.com
