Process Validation - QA

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.