Quality manager
Macro Group Pharmaceuticals
Total des années d'expérience :13 years, 10 Mois
1. Manages the Quality departments daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
2. Hires, trains, motivate leads, develop and evaluate staff. Takes corrective action as necessary on a timely basis and in accordance with company policy.
3. Ensures compliance with current state and local regulations.
4. Ensures Quality systems are compliant with corporate and site procedures, as well as industry standards.
5. Interacts with suppliers during meetings and visits
6. Works in conjunction with other departments to develop, qualify, and transfer QC analytical methods.
7. Ensures maintenance of QC equipment - qualification, calibration and maintenance.
8. Participates in Validation Team and Project Teams, as applicable.
9. Drafts, reviews, and approves Standard Operating Procedures (SOP), sampling plans, specifications, protocols and reports related to product/processes, equipment, method, validation. This includes deviation investigation and reporting.
10. Develops and implements statistical tools for Quality Systems monitoring and review.
11. Participate in the study of any changes to critical processes, facilities, equipment and systems through the change control program to assess impact on validated systems.
12. Assists in supplier / regulatory audits and responding to audit observations and corrective actions.
13. Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes.
14. Collaborates significantly with cross functional groups, including QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
15. Provides technical assistance and training for personnel
16. Files and maintains controlled documents.
17. Other duties as assigned
Master degree for organic chemistry with Analytical bio-chemistry diploma from the same university