Senior Validation Specialist

6 days ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Description

We are seeking a highly skilled Senior Validation Specialist to join our team at RECRUIT EXPRESS PTE LTD.

About the Job

This is a 6-month contract position with an estimated salary of $4500 - 8000 (Depending on experience).

Key Responsibilities:
  • Support site projects on Qualification/Validation, Assessment and Approval of Documents.
  • Review and approve Quality Control related protocols, reports, procedures, and other documents for compliance to internal procedures and regulatory requirements.
  • Evaluate and approve discrepancies related to qualification/validation protocols to guarantee documentation of incidents and identification of corrective actions.
  • Collaborate and participate in projects as Quality Representative for Quality Systems and Validation.
  • Provide validation expertise, oversight, and support for development phases of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.
  • Ensure information contained in approved qualification/validation documents is understandable and defendable during inspection.
  • Provide quality oversight on Quality Control validation maintenance activities and Master Validation Plan.
  • Support multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between plants.
  • Build strong partnerships with all departments to ensure open communications and acceptance.
  • Responsibility to adhere to any applicable EHS requirements.
Requirements:
  • Min. Degree in any relevant science field preferably in pharmaceutical or life sciences.
  • Addtional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages.
  • Min. 2-3 years relevant experience in pharmaceutical or biotechnology in quality assurance, manufacturing operations or validation.
  • Hands-on experience with performing equipment, process, cleaning, computer systems & shipping validation will be advantages. FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and various validation guides such as PDA Technical guides, ISPE GAMP guides etc.


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