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 recent 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.).

📌 Officer Executive Ahmedabad
🏢 Halewood laboratories
📍 Ahmedabad