QA Validation Manager

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Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries ?
PQE Group
has been at the forefront of these industries
since 1998 , with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas .
Due to our constant growth, we are looking for a
QA Validation Manager
to support our projects in
Singapore.
Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained
Accountable for QA Review of all Qualification and Validation protocols and reports, including QC instruments, facilities, utilities systems and computer systems.
Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements
Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits.
Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
Carry out additional tasks as assigned by leadership.
About you:
Bachelor's degree or higher in Pharmacy, Biologics, Pharmaceutical Engineering, or related scientific field.
At least 5 years of relevant QA experience in Biopharma or Pharmaceuticals
Strong knowledge of FDA, EMA, and PIC/S GMP requirements.
Knowledgeable in biological product manufacturing and related quality control requirements.
Experience in biopharma commercial supply is preferred.
Hands-on experience in review/approval of validation deliverables (equipment, utilities, computer systems).
Familiarity with data integrity requirements and electronic validation documentation.
Strong analytical, problem-solving, and communication skills.
Fluency in English.
Chinese nice to have
First Project you will be assigned to:
Availability : Full on-site
Type of Contract : 6 months renwable
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation . PQE Group gives you the
opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world. If you are looking for a
rewarding and exciting career , PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Contract
Job function
Job function Manufacturing, Quality Assurance, and Project Management
Industries Business Consulting and Services and IT Services and IT Consulting
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