
Pharmaceutical Quality Assurance Professional
1 week ago
We are seeking an experienced pharmaceutical quality assurance professional with expertise in regulated environments for a role in Singapore.
The ideal candidate will have strong knowledge of regulatory guidelines, including FDA, EMA, ICH, ISPE, and GAMP 5.
Key Responsibilities:- Draft, review, and execute qualification plans, protocols, data integrity assessments, security assessments, and qualification summary/completion reports.
- Ensure all documentation complies with good documentation practices, GxP, and regulatory requirements.
- Collaborate with quality control subject matter experts to capture and align user requirements for the qualification of new laboratory and production equipment.
- Participate in risk assessments and define qualification strategies in alignment with project and regulatory requirements.
- Liaise with equipment vendors and service providers to review, assess, and approve vendor-supplied documentation such as installation and operational qualification protocols.
- Coordinate execution of vendor IOQs and support resolution of technical or compliance issues.
- Support deviation management, change control, and CAPA activities related to qualification and commissioning projects.
- Contribute to continuous improvement initiatives to streamline CQV processes and enhance efficiency.
- Bachelor's degree in engineering, life sciences, or a related discipline.
- Experience in commissioning, qualification, and validation in a regulated pharmaceutical/biopharma environment.
- Strong technical writing, analytical, and problem-solving skills.
- Excellent coordination, communication, and stakeholder management abilities.
We value everyone's unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel, and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
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