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验证工程师
2 weeks ago
Work Your Magic with us
Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role will lead site qualification& validation and ensure that qualification& validation activities consistently comply with all regulatory and corporate requirements in support of regulatory (Chinese GMP, EU GMP, ISO and applicable agencies) and customer expectations.
This position will also entail site computerized system validation (CSV) and validation Management system build-up and maintenance, to ensure CSV and validation management system compliance with all Domestic and Global regulatory and corporate requirements.
Your Role
- Establish local procedure for qualification and validation lifecycle management (i.e.: VMP, VP, URS, FS, DS, Protocols, Reports), and ensure that local management procedure complies with qualification & validation regulatory requirements.
- Establish local procedure for computerized system validation (CSV) lifecycle management (i.e. risk assessment, validation planning, execution and reporting, post-validation status maintenance, de-commissioning), and ensure that local management procedure complies with GxP validation regulatory requirements.
- Write VMP, Validation Plans and protocols for facilities, equipment, utilities, production processes, cleaning, and Computerized Systems in collaboration with Subject Matter Experts, ensure validation documents comply with regulatory requirement, Merck life science global and local quality standards.
- Create VMP, validation Plans and Protocols including DQ, IQ, OQ, PQ, process validation and cleaning validation.
- Lead validation risk assessment to identify validation scope and extent, ensure validation work is well organized and validation requirements are fulfilled including CSV requirement.
- Coordinate URS creation, lead and supervise DQ/IQ/OQ/PQ execution including test execution witness and result review.
- Review and approve Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors. Supervising contractors performing commissioning and qualification activities.
- Specify, select, and coordinate purchase of testing equipment and associated consumables used in execution of qualification Protocols.
- Coordinate and supervise test execution for process validation and cleaning validation, review of validation results.
- Review Validation Deviations and managing their closure by the agreed dates.
- Review validation report, prepare and approve validation summary reports.
- Carry out periodic validation status review and manage site requalification and revalidation.
- Lead Post-CSV validation status maintenance including system register updating, configuration management, security management, audit trail review, ERES, service level agreement, backup and recovery, data Retention, Archiving and Retrieval, business continuity planning, periodic validation status review and etc, manage site CSV compliance with GxP requirements consistently.
- Identify validation requirements for proposed changes and corrective actions.
- Present validation status of systems and processes to Regulatory Agencies and at customer quality audits.
- Comply with corporate and site safety procedures.
- Actively participate in quality culture building and quality related activities.
- Actively report quality related events and participate in continuous quality improvement activities.
Who You Are
Education: BS in automation, IT, Pharmaceutical or equivalent.
Working Experience: ≥8 years' experience in pharmaceutical &chemical plant.
Experience and knowledge in validation and qualification.
Fluent in English.
Result orientation, accuracy and reliability as a must.
Excellent communication, problem-solving, planning and organization skills.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity
