QA Specialist

2 days ago

Tuas, Singapore e3ea4ea3-b52a-45a6-9cad-56e43cc104a1 Full time $48,000 - $72,000 per year

KEY DUTIES AND RESPONSIBILITES:

  • Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
  • Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
  • Candidate must have knowledge and experience of qualification/validation principles and their practical application.
  • Preparation and review of process and cleaning validation protocols and reports.
  • Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
  • Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
  • Write, review, and revise validation SOPs in compliance with regulatory guidelines.
  • QA oversight and/or review during the validation process.
  • Manage incidents and deviations related to validation & qualification.
  • Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
  • Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
  • Cross train and develop expertise in other areas of validation.
  • Must be able to interact and lead effectively in a team-based environment.
  • Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE

  • Degree a scientific discipline or equivalent.
  • Experience in a regulated industry preferred.
  • Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
  • A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environment.

We regret that only shortlisted candidates will be contacted.

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