Key Responsibilities
Validation Strategy & Documentation
- Prepare comprehensive validation protocols, reports, and master plans for various dosage forms including OSD, oral liquids, and topical formulations.
- Define validation strategy in line with current regulatory expectations and industry best practices (e.g., FDA, EMA, WHO).
- Implement a life cycle approach to validation covering development, execution, monitoring, and revalidation.
Cleaning Validation
- Execute and oversee cleaning validation activities.
- Select worst-case products based on matrixing, carry out swab and rinse sampling.
- Design and validate sampling plans, calculate MACO, and determine acceptance criteria.
- Prepare and review cleaning validation protocols and reports.
Process Validation
- Conduct process validation (PV) for new and existing products.
- Draft and execute validation protocols including BMR/BPR reviews.
- Participate in risk assessments (e.g., FMEA) and root cause analysis as needed.
Equipment & Utility Qualification
- Prepare and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform equipment and utility qualifications (HVAC, purified water systems, compressed air, etc.).
Hold Time Studies
- Plan and execute hold time studies for bulk, intermediate, and finished products.
- Analyze data and compile reports in accordance with regulatory expectations.
Sampling Plan & Worst Case Matrixing
- Design effective sampling plans based on worst-case scenarios, product complexity, and manufacturing practices.
- Perform matrix selection for cleaning and process validation.
Compilation & Compliance
- Ensure end-to-end compilation of validation documentation in compliance with cGMP.
- Participate in internal/external audits and provide technical support during regulatory inspections.
Required Qualifications
- Bachelor's / Master's Degree in Pharmacy, Pharmaceutical Sciences, or a related field.
- Minimum 5 years of experience in validation within formulation development (OSD, oral liquids, topical).
- Sound knowledge of regulatory guidelines (USFDA, MHRA, EMA, WHO, etc.).
