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

Preparation/review of:

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)

Handling

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

Senior Executive