Job title: manufacturing quality manager
we are seeking a skilled manufacturing quality manager to oversee all aspects of quality for our cosmetic and otc manufacturing facility in tijuana, mexico.
1. manage daily functions of all quality laboratories, review and approve documentation generated by those labs, assign tasks to personnel as necessary, interact daily with production management, troubleshoot quality issues, make recommendations for resolution.
2. supervise validation, calibration, iq/oq/pq, oos/capa, ncmr, deviations, writing and updating sops, review and sign-off on sops issued by functional areas throughout the facility.
3. supervise and coordinate all quality-related employees, manage resources, processes, procedures, and employee behavior.
4. manage otc stability program, collaborate with engineering department and other functional areas in the review and issuance of swis, ensure annual product review (apr) for drug products is completed by the end of the first quarter of following year.
5. conduct routine audits of manufacturing areas, laboratories, quality systems, generate reports with recommendations, drive immediate resolution for non-compliance, co-host fda and third-party audits.
6. supervise and document training program for quality employees, track and monitor training of new hires by functional area supervisors, recommend additional training, education to assure progressive departmental advances.
7. provide decisive leadership, manage manpower requisitions, hire qualified personnel, conduct employee reviews, manage daily quality operations in the tijuana plant, assure capable qualified processes for the manufacturing of products, execute compliance with all applicable regulations.
8. act as delegate quality systems management representative as required, ensure operational plans are aligned with business objectives, apply expertise to achieve financial and operational objectives, execute compliance with 21 cfr 211 and iso 22716, comply with safety, health and environmental control measures set out in the company's rit.