QA Specialist (QMS/ Validation/ BioTech/ Pharma)
Duration: 6 Months Contract (Convertible)
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.
- 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
- 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.email@example.com
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579