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Open nowPosted 5 days ago

Senior Specialist - Quality Assurance (Validation)

PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

Pay
SGD 5,000 – SGD 6,000 a month
Where
West, Singapore
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Your applicationOpen nowSenior Specialist - Quality Assurance (Validation)PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. · West, Singapore

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.7%14 days
  5. 35.6%30 days
  6. 58.0%60 days
This job: posted 5 days ago

The posting

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.
  • A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
  • Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

TO APPLY:

Candidates are encouraged to apply this position via email to [email protected] with the following information in the resume.

  • Work experiences and job responsibilities
  • Current and Expected salary
  • Reason for leaving
  • Date of availability
  • Education background

We regret that only shortlisted candidates will be contacted.

Posting text belongs to the employer. Removal requests: contact us.

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