Officer -Executive

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.).