Senior Associate - Validation

Key Skills:

Roles & Responsibilities:

• Perform specialized technical tasks and conduct research to optimize validation outcomes.
• Ensure equipment, systems, and processes operate effectively and comply with regulations.
• Conduct risk assessments, design protocols, analyze data, and prepare validation and qualification reports.
• Verify that products and processes meet predefined criteria.
• Support validation activities for aseptic process management.
• Review and approve change control documentation.
• Provide audit support and develop protocols for product transfers and launches.
• Make decisions within the scope of assigned tasks, requiring advanced technical knowledge and analytical skills.
• Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs) and maintaining accurate documentation.
• Ensure rigorous quality control, complete all required training, and contribute to overall compliance.
• Commit to continuous improvement and compliance with regulatory requirements.

Experience Requirement:

• 4 - 8 years of experience in medical device or pharmaceutical validation.
• Hands-on experience in equipment, process, system, and facility validation and qualification.
• Experience performing risk assessments, designing protocols, executing validation tests, and analyzing results.
• Familiarity with aseptic process validation and sterile product handling is a plus.
• Exposure to change control, audit support, and regulatory compliance documentation.
• Experience preparing validation reports, deviation reports, and validation summaries.
• Knowledge of Good Manufacturing Practices (GMP), Good Practice regulations (GxP), and Standard Operating Procedures (SOPs).
• Ability to collaborate with cross-functional teams in quality, regulatory affairs, engineering, and manufacturing.

Education: