Biotech Quality Assurance Specialist
1 week ago
About PSC Biotech
PSC Biotech is a leading biotech consultancy firm founded in 1996. We provide cloud-based software solutions for quality management, regulatory inspections, and pharmaceutical contract manufacturing professionals.
As a quality assurance specialist at PSC Biotech, you will have the opportunity to work with a talented cohort of like-minded professionals in the pharmaceutical industry.
We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Key Responsibilities
- Provide direct quality support to a production area as part of a quality IPT (Integrated Product Team)
- Ensure quality and compliance of products manufactured by the functional area
- Review process documentation/data for accuracy, completeness, and data integrity compliance
- Conduct investigations of deviations and participate in continuous improvement initiatives
- Support the completion of batch disposition activities for release of product
Requirements
- Minimum 5 years of relevant post-degree work experience in GMP manufacturing, quality assurance, or laboratory environment
- Expertise in QA operations and regulatory agency engagement an advantage
- Candidates should possess strong leadership skills, good oral and written communication skills, and understanding of cGMPs and regulatory requirements
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