Sr.Manager/Manger - QA Validations

Key Responsibilities

• Lead and oversee process validation, cleaning validation, aseptic process validation and hold-time studies.
• Review and approve validation protocols, reports, risk assessments and related QA documentation.
• Manage equipment, facility, utility and system qualification activities including DQ, IQ, OQ and PQ.
• Ensure validation lifecycle activities are executed in accordance with approved procedures and regulatory expectations.
• Provide QA oversight for media fills / aseptic process simulations (APS) and related investigations.
• Review validation deviations, OOS/OOT, change controls and CAPA associated with validation activities.
• Ensure continued process verification (CPV) and periodic review of validated processes.
• Coordinate with Production, Engineering, QC, R&D, Regulatory and other cross-functional teams.
• Support and represent the Validation function during regulatory inspections and customer audits.
• Identify compliance gaps and drive timely remediation and CAPA implementation.
• Ensure validation documentation is ALCOA+ compliant, traceable and inspection-ready.
• Develop and mentor the QA Validation team and ensure effective resource planning.
• Review validation master plans and establish validation strategies for new products, processes and equipment.

Key Areas of Expertise

• Sterile Injectable / Aseptic Manufacturing
• Process & Cleaning Validation
• Aseptic Process Simulation / Media Fill
• Equipment & Utility Qualification
• HVAC / Water System Qualification
• Computerized System Validation
• Sterilization & Depyrogenation Validation
• Validation Risk Assessment
• Change Control, Deviation & CAPA
• Continued Process Verification
• Regulatory Inspection Readiness

Desired Profile

• 15-20 years of experience in QA/Validation within pharmaceutical manufacturing, preferably sterile injectable facilities.
• Strong knowledge of USFDA, EU GMP, WHO GMP, Schedule M and ICH guidelines.
• Experience in handling regulatory/customer audits and inspection observations related to validation.
• Strong leadership, documentation review and cross-functional coordination skills.
• Experience in new facility / new product validation and technology transfer will be an advantage.