QA Specialist (QMS/ Validation/ BioTech/ Pharma)

Location Singapore
Discipline Life Sciences
Job Reference BBBH135572_1706606514
Salary S$5000 - S$6500 per month
Consultant Email apple.lim@manpower.com.sg
EA License No. 02C3423


QA Specialist (QMS/ Validation/ BioTech/ Pharma)

Duration: 6 Months Contract (Convertible)
Location: Tuas
Salary : Up to $6000 depending on experience

Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.

Responsibilities

  • Responsible to review and approve validation protocols, reports, risk assessment and other validation related documents for equipment's, computerized systems, HVAC & utility systems, process validation, Analytical & Microbiology methods etc.
  • To ensure validation documents are compliance with internal procedure or regulatory requirements.
  • Responsible to review and approve specification documents in compliance with validation requirements.
  • Support the review of the validation related standard procedures.
  • Support internal and external audit inspection.
  • Quality oversight for validation maintenance program.
  • Collaboration with cross functional team for site improvements
  • Adherence to safety requirements



Requirements:

  • Degree in pharmaceutical science or related discipline.
  • A minimum experience of 3-5 years in Pharmaceutical in the field of Quality Assurance or Validation.
  • Hands-on experience on validation / qualification of manufacturing equipment's/ systems etc.
  • Deep knowledge on various validation regulatory guidelines such as FDA/EU cGMP, PDA Technical guide, GAMP requirements etc.
  • Knowledge on Data Integrity and Compliance with cGMP



Lim Pey Chyi (Apple) - Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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