QA Associate Regulatory Compliance

Position: QA Associate for Regulatory Compliance
Be an integral part of quality assurance as a QA Associate focused on batch release. Ensure compliance and precision in the production of radiopharmaceuticals through meticulous documentation review.

In this position, you'll verify that all batches meet specifications, ensuring adherence to cGMP and other regulatory guidelines. Collaborating cross-functionally, you will handle media fill reviews, support new product launches, and maintain effective communication with stakeholders regarding batch issues. Attention to detail and an organized approach will be key in this role.

Key Responsibilities:

• Oversee the final disposition of drug product batches

• Review and analyze compliance documentation

• Lead media fill reviews and resolve discrepancies

• Release materials using an ERP system

• Support audits and inspections by regulatory agencies

Requirements:

•

B.Sc or M.Sc in life sciences with 2-5 years of expertise

• In-depth knowledge of FDA and EU GMP regulations

• Exceptional detail-oriented and communication skills

• Flexible for a round-the-clock operational schedule

Join the effort in promoting compliance and quality throughout the production lifecycle of radiopharmaceutical products.
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