Senior Validation Specialist

Posted 15 Apr 2019

Nantong, Jiangsu - China

Req Id 190838


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.

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

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!

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