What are the responsibilities and job description for the Plant Quality Manager position at HTI?
JOB SUMMARY:
To plan, organize and supervise the activities of auditing, in-process and finished product inspection in manufacturing and packaging to ensure regulatory compliance, safety and quality pharmaceutical products.
The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILIITIES:
- Comprehend, maintain and promote cGMP and SOP compliance in FDA/DEA regulated pharmaceutical manufacturing environment, ensuring product integrity, safety and compliance standards.
- Manage and supervise the daily activities of the Plant Quality inspection team on all shifts to ensure oversight of operations process.
- Train, coach and mentor QA personnel, ensuing that training records are complete and accurate.
- Be proficient in all areas of manufacturing and packaging inspection process.
- Write, review and participate in investigations as required. Segregate , quarantine and complete documentation for non-conforming materials.
- Review and approve standard operating procedures, work instructions and policies. Review and approve investigations in the Quality Management System. Review and approve Change Control Forms.
- Help identify and lead on-going initiatives for continuous improvements to PAI’s quality process. Create and revise SOP’s and WI’s. Support validation activities by ensuring that
protocol requirements are being met.
- Provide timely updates to Quality Management. Work directly with other departments to provide support for manufacturing and packaging activities.
- Support compliance with participating in audit preparations and participate as needed in FDA Inspections and FDA readiness. Participate in agency and customer inspections.
- Contributes to the accomplishment of the objectives and goals of PAI and executive management.
- Perform other related duties as required or assigned.
EDUCATION AND/OR EXPERIENCE:
Bachelors’ Degree or equivalent experience resulting in broad knowledge of a field related to the job, plus 5 years related experience and/or training, and 5 years related management experience, or equivalent combination of education and experience.
