Compliance Lead

1 week ago


Manassas, Virginia, United States Granules Pharmaceuticals Full time
About the Role

This is an excellent opportunity for a skilled Quality Assurance professional to work with a leading pharmaceutical company in the US market. The Senior QA Associate, Compliance/QA Lead will play a vital role in ensuring that our products meet the highest standards of quality and safety.

The ideal candidate will have hands-on experience in implementing Serialization and aggregation processes, as well as knowledge of Good Manufacturing Practices (cGMP). They will also have excellent communication and problem-solving skills, as well as the ability to work effectively in a fast-paced environment.

Responsibilities
  • Implement plans for gap closure and follow up on the corrective actions to ensure sustainable cGMP Compliance.
  • Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA).
  • Conduct assessment of cGMP Compliance gaps.
  • Review and release of the batches.
  • Participation in qualification of utilities, systems, and equipment on-site
  • Support training programs to ensure competency of personnel engaged in cGMP activities.
  • Support all aspects of investigations, including out-of-specification and manufacturing investigations.
  • Perform routine trouble shooting of cGMP excursions including determination of root cause analysis.
  • Assist other analyses of data, and interpretation.
  • Maintain and update key Quality metrics for assessment of cGMP at the Manassas site.
  • Identify and communicate continuous improvement opportunities to the Quality Assurance Manager.
  • Responsible for the safe and efficient execution of job duties and abiding by established quality standards.
  • Exposure to enhance skills to develop a better understanding of applying and interpreting FDA regulations to medicinal drug products.


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