Responsible for planning, coordinating, executing, reviewing, and maintaining process validation activities in compliance with GMP, regulatory requirements, approved protocols, and company procedures for OSD manufacturing operations.

Key Responsibilities

- Prepare, review, and execute Process Validation Protocols and Reports for OSD products.

- Plan and coordinate process validation activities for tablets, capsules, and other OSD products.

- Ensure validation activities are performed as per approved protocols, SOPs, GMP, and regulatory requirements.

- Coordinate with Production, IPQA, QC, Engineering, R&D;, and other cross-functional departments for validation activities.

- Review manufacturing processes, batch records, process parameters, and critical process parameters (CPPs).

- Identify and evaluate Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) related to manufacturing processes.

- Ensure proper sampling, testing, and documentation during process validation batches.

- Review validation data, analytical results, process trends, and statistical evaluation where applicable.

- Prepare and review Process Validation Reports (PVR)



and ensure timely closure of validation activities.

- Handle validation-related deviations, incidents, CAPA, and change controls and assess their impact on validated processes.

- Perform validation impact assessments for Change Controls and support revalidation activities.

- Coordinate and monitor Continued Process Verification (CPV) activities.

- Review process performance and identify trends or potential risks requiring improvement or revalidation.

- Maintain and update the Validation Master Plan (VMP) and validation schedules, where applicable.

- Ensure validation documentation is complete, accurate, traceable, and audit-ready.

- Support regulatory inspections, customer audits, and internal audits related to process validation.

- Ensure compliance with applicable GMP, WHO-GMP, EU-GMP, and other regulatory requirements.

- Participate in risk assessments related to process validation and manufacturing processes.

- Support continuous improvement of validation systems and QA processes.

📌 Process Validation - QA (Ahmedabad)
🏢 BioMatrix Healthcare
📍 Ahmedabad