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 current facility / new product validation and technology transfer will be an advantage.

📌 Sr.Manager/Manger - QA Validations (Jadcherla)
🏢 Aspiro Pharma
📍 Jadcherla