Lead QA Specialist - Operations
A global industry pharmaceutical leader with commercial products available across multiple therapeutic areas is seeking an experience Lead QA Specialist to take a key position in their Quality Assurance organization. You will be supporting the development of trusted medicines and continuing to advance innovative and sustainable solutions.
Key responsibilities:
- Engage in the training and development of QA team members, including Specialists, Senior Specialists, and Supervisors, focusing on QA Operations functions and GMP regulations.
- Lead and participate in quality improvement initiatives and cross-functional teams, offering QA insights. Assist management with strategic planning for intermediate batch record review/release, finished product batch record review, and other QA Specialist floor operations.
- Supervise the evaluation and triage of events, deviations, and unplanned maintenance activities by QA Specialists. Oversee the On-Hold material program, mentoring QA team members in monitoring and disposition of material.
- Conduct QA review and approval of controlled documents, written procedures, protocols, and MES recipes as required. Compile and provide information for inclusion in monthly quality metric reports.
- Ensure deviations are appropriately reported and participate in investigations of deviations as required. Support the review and approval of Trackwise® incidents related to manufacturing operations. Identify and implement continuous improvements for the elements of the quality system related to manufacturing operations.
Qualifications:
- A BS degree and 8+ years of relevant experience in a GMP environment, with comprehensive knowledge of Quality Systems and cGMP. A combination of experience and/or education will be considered.
- Effective written and oral communication and interpersonal skills, with the ability to work constructively across functional areas to achieve results.
- Should have a solid understanding of quality frameworks for the pharmaceutical sector, including current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH) guidelines, and pharmacopoeial standards, as well as for medical products, such as ISO and IPEC standards.
- Proficiency with computer systems and various software applications like Microsoft Word, Excel, Access, and Project is required.
