Quality Assurance Manager
13 hours ago
Pharmalogic Holdings is a leading provider of radiopharmaceutical solutions. We are seeking a highly skilled Quality Assurance Manager to join our team.
The successful candidate will be responsible for ensuring compliance with cGMP and other regulatory standards for the manufacture of drugs. This will involve completion of quality assurance tasks, including materials acceptance and quarantine, batch release and record review, drug quality control, sterility, environmental monitoring, equipment maintenance and qualification, investigation and corrective actions.
The site QA Manager will also be responsible for training documentation for staff on QA related activities and will be the responsible person for FDA inspections at the site.
Key Responsibilities:
- Ensure compliance with all regulatory commitments and company policies and SOPs.
- Actively promote adherence to SOPs, as well as safety rules and awareness.
- Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary.
- Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity.
- Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment.
Requirements:
- Strong knowledge of cGMP and regulatory standards.
- Excellent communication and leadership skills.
- Ability to work in a fast-paced environment.
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