Compliance Lead
1 week ago
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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