Pharmaceutical Quality Assurance Leader
2 weeks ago
Position: Pharmaceutical Quality Assurance Leader
The Pharmaceutical Quality Assurance Leader is essential in upholding the utmost quality and safety standards for our pharmaceutical offerings.
Your role encompasses overseeing all Quality Assurance facets of sterile pharmaceutical compounding to ensure compliance within our operations. You will lead the QA team, coordinating daily activities while adhering to legal and regulatory requirements to deliver a superior product.
Your meticulous attention to detail and strict adherence to established protocols will ensure that our medications consistently meet the highest benchmarks for safety, efficacy, and quality, ultimately enhancing patient care and outcomes.
Key Responsibilities:
- Direct Quality Assurance initiatives to guarantee adherence to procedures and oversee production aspects to ensure the delivery of a quality drug product, focusing on safety, strength, identity, purity, and potency, particularly for sterile products.
- Conduct regular reviews of documentation to assess quality standards for each drug product, identifying trends and determining necessary adjustments to specifications or control processes.
- Oversee the final review and approval of all cGMP documentation, including SOPs, Instructions, Protocols, Specifications, Forms, and Master Batch Records.
- Maintain both electronic and paper records of master batch processes and approvals.
- Manage the disposition of batch documentation for manufactured products.
- Facilitate communication and coordinate product release with Operations to ensure timely product availability.
- Ensure that employee qualification programs for relevant activities are up-to-date and that general training is current.
- Review and approve unexpected results or failures, along with environmental and personnel monitoring outcomes that exceed established limits, directing subsequent improvement initiatives.
- Provide review, impact assessment, and approval of changes in accordance with Xseer Change Management protocols.
- Ensure that Quality Systems align with current Good Manufacturing Practices, ensuring compliance throughout the facility lifecycle.
- Participate in regulatory inspections related to Quality Systems and operations.
- Maintain QA records associated with both internal and external testing.
- Analyze process flows and conduct gap assessments to drive continuous improvement.
Qualifications:
- A minimum of a four-year degree in Engineering or Life Sciences.
- At least four years of experience in pharmaceutical Quality Assurance, with a focus on cGMP compliance.
- Previous experience and understanding of the 503B industry and cGMP requirements relevant to Section 503B of the FD&C Act.
- Experience in quality systems with demonstrated science-based decision-making capabilities.
- Comprehensive knowledge of cGMP, FDA, USP, and pharmacy state board regulatory guidelines.
- Strong interpersonal and group skills, with the ability to motivate and lead teams.
- Excellent communication skills, both verbal and written, along with proficiency in basic computer applications (e.g., word processing, spreadsheets).
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