Senior Validation Specialist
4 weeks ago
The Validation and Qualification Manager is responsible for overseeing the qualification and validation activities to ensure compliance with Good Manufacturing Practices (GMP) and PICS guidelines for a supplement manufacturing facility. They will develop and execute validation protocols, oversee testing and documentation, and collaborate with cross-functional teams to maintain the qualified status of equipment, processes, and systems.
Key Responsibilities- Ensure that all qualification and validation activities are conducted in compliance with GMP and PICS guidelines
- Review and approve validation documentation, including protocols, reports, and change control records
- Collaborate with production, engineering, and maintenance teams to address deviations and implement corrective actions
- Maintain a comprehensive validation documentation system and archive
- Conduct periodic reviews and re-validations to ensure the ongoing qualified status of critical systems and processes
- Stay up-to-date with regulatory requirements and industry best practices in qualification and validation
- Provide training and guidance to cross-functional teams on validation procedures and requirements
- 1-3 years of experience in validation and qualification management in a GMP-regulated pharmaceutical or supplement manufacturing environment
- Candidates with more years of experience would be considered for a Senior QA Officer role
- Strong understanding of GMP and PICS regulations related to qualification and validation
- Proficiency in developing and executing validation protocols and reports
- Experience in managing the qualification of equipment, processes, and systems
- Excellent problem-solving, analytical, and critical thinking skills
- Effective communication and collaboration skills to work with cross-functional teams
- Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field
- A career opportunity with the market leader in health product sector
- Comprehensive health insurance from your first day at work
- Casual wear everyday to enjoy your work
- Free and convenient shuttles from various locations
- Generous leave policies, including paid annual leave, birthday leave, and other special leaves
- Many opportunities to learn and grow together
- Rapid growth opportunities for strong performers
- Attractive staff purchase discount from your first day at work
- And more
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