Purpose
Responsible for planning, execution, review, and lifecycle management of validation and qualification activities in compliance with global regulatory requirements (USFDA, EU-GMP, WHO). Ensures data integrity, documentation compliance, and coordination across cross-functional teams. Hands-on experience with SAP for quality and material management processes is essential
Position / Job Title
Executive to Sr. Executive
Department
Corporate Quality Assurance (CQA
Location
Chhatrapati Sambhaji Nagar
Years of Experience
07 to 09 years
Dosage Form
Solid Oral / Nasal / Liquid
Job Responsibilities
- Validation & Qualification Management
- Preparation, review, and approval of:
oUser Requirement Specifications (URS)
oDesign Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
oComputer system validation (CSV)
oQuality Control laboratory equipment qualification
oSOP and Protocols preparation; review and approval
oExecution of FAT/SAT and commissioning support
oLayouts (equipment, HVAC zoning, material/personnel flow)
- Facility & Utility Qualification
- Qualifications of:
oHVAC systems (classification, airflow, HEPA validation)
oWater systems (PW/WFI loop design & qualification)
oCompressed air, nitrogen, clean steam
oIQ, OQ, PQ protocols and reports
- Commissioning & Qualification (C&Q) Strategy
- Development of
oValidation Master Plan (VMP) for new facility
oCommissioning & Qualification strategy (C&Q plan)
- Computer System Validation (CSV)
- Qualification of:
oSCADA / PLC system
oLIMS / QMS system
- Lifecycle Approach & Compliance
- Implementation of lifecycle validation approach as per ICH Q8/Q9/Q10
- Risk assessment using tools like FMEA, HACCP
- Ensuring compliance with 21 CFR Part 11, data integrity (ALCOA+ principles)
- Periodic review of validated systems and processes
- SAP & Digital Systems Handling
- Working knowledge of SAP modules:
oSAP QM (Quality Management)
oSAP MM (Material Management)
oMaterial master creation/review
oChange control and deviation
Qualifications & Pre-Requisites
Bachelor / Master of Pharmacy / Master of Science
Experience in USFDA, EU, MHRA, WHO regulatory environments and requirements of contract manufacturing operations specifically formulation point of view
Additional notes
Shall be coordinated with other Rubicon sites for review of documents as per requirement
