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:
Edu c a t i o n: Bachelor or above.
W o r k in gExperience:
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)
T e c hn i c a l &ProfessionalKnowledge:
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
Job Requisition ID: 210440
Career Level: C - Professional (1-3 years)
Working time model: full-time
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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