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Senior Validation Specialist

Your role:

Role Description:

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 site computerized system validation (CSV) and validation Management system buildup and maintenance, to ensure CSV and validation management system compliance with all Domestic and Global regulatory and corporate requirements.

Job Description

  1. 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.
  2. 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.
  3. 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 regualtory requirement, life science global and local quality standards
  4. Create VMP, validation Plans and Protocols including DQ, IQ, OQ, PQ, process validation and cleaning valiation.
  5. Lead validation risk assessment to identify validation scope and extent, ensure validdation work is well organized and validation requirements are fulfilled including CSV requirement.
  6. Coordinate URS creation, lead and supervise DQ/IQ/OQ/PQ execution including test execution witness and result review.
  7. Review and approve Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors. Supervising contractors performing commissioning and qualification activities.
  8. Specify, select, and coordinate purchase of testing equipment and associated consumables used in execution of qualification Protocols.
  9. Coordinate and supervise test execution for process validation and cleaning validation, review of validation results.
  10. Review Validation Deviations and managing their closure by the agreed dates.
  11. Review validation report, prepare and approve validation summary reports.
  12. Carry out periodic validation status review and manage site requalification and revalidation
  13. 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.
  14. Identify validation requirements for proposed changes and corrective actions.
  15. Present validation status of systems and processes to Regulatory Agencies and at customer quality audits.

    16.  Comply with corporate and site safety procedures.

Who you are:

    • BS in automation, IT, Pharmaceutical or equivalent.
    • More than 6 years' experience in pharmaceutical &chemical plant.
    • Familiar with GMP requirements and GAMP 5.
    • Experience and knowledge in validation and qualification

Competencies & Skills:

    • Fluent in English
    • Result orientation, accuracy and reliability as a must
    • Excellent communication, problem-solving, planning and organization skills

Functional area: Quality

Job Requisition ID:  190838
Location:  Nantong
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
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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