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高级验证专员

A career at Merck 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 electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role:

Overall Objectives of the Position

  • The Sr. 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.

Main Tasks 

  • 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.
  • 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.
  • Coordinate and execute test for thermal mapping.
  • Leading site CCM/RTU validation/qualification activity and related project.
  • 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 and Qualification Required 

  • Education: Bachelor or above.
  • WorkinExperience:

              1. Minimum 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)

         4. Must have sterile experience and related operation experience.

  • Technical & ProfessionaKnowledge:

        1. Well verse in spoken and written English language, as well as a native Chinese language capability.

        2. Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook)

        3. Inter-cultural competence, problem-solving and good communication skill

HR: 95989

Functional Area: Quality

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Job Requisition ID:  253109
Location:  Nantong
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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