Process Validation Specialist

About the role

The Process Validation Specialist will monitor on‑site production activities and support validation batches for new product projects. This role ensures that manufacturing and packaging processes meet safety and quality standards while contributing to product transfer and annual review activities.

Key responsibilities

• Monitor production operations and participate in process validation batches for new products.
• Prepare and revise manufacturing, packaging, process validation, and cleaning validation protocols and reports.
• Develop and update documentation for new product processes and Annual Product Review (APR) activities.
• Coordinate communication with relevant departments and external partners during product transfer projects.
• Maintain and monitor Quality Assurance SOPs related to product transfer.

Required profile

• Bachelor’s degree in Chemistry, Chemical Engineering, or Biology.
• Minimum 2 years of Quality Assurance experience in the pharmaceutical industry.
• Advanced English proficiency.
• Strong knowledge of GMP, manufacturing, and quality control processes.
• Experience with regulatory submissions and product registration.
• Excellent teamwork, analytical thinking, and project‑tracking abilities.

Required skills

• Process validation
• Cleaning validation
• Good Manufacturing Practices (GMP)
• Regulatory submission and product registration
• Project tracking
• Advanced office software proficiency

What we offer

• Opportunity to work on cutting‑edge pharmaceutical projects.
• Collaborative environment with cross‑functional teams.
• Professional development in quality assurance and validation.