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A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Overall Objectives of the Position:
- The Validation specialist role will lead site qualification& validation and ensure that qualification& validation activities consistently complies 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 validation Management system build-up and maintenance, to ensure the system compliance with all Domestic and Global regulatory and corporate requirements.
- 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.
- 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
- Lead validation risk assessment to identify validation scope and extent.
- 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
- 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.
Who you are:
Education: Bachelor or above.
1. 3-5 years of working experience in a pharmaceutical or biological GMP/ISO environment with some auditing experience.
2. Expert knowledge of domestic and international regulations regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for Active Pharmaceutical Ingredients (APIs) and pharmaceutical/biological products.
3. In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series)
Technical & Professional Knowledge:
1. Well verse in spoken and written English language, as well as a native Chinese language capability.
2. Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)
3. Inter-cultural competence
4. Willing and being able to travel at least 50% of the time.
Functional Area: Quality
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!