Position: Quality Assurance Supervisor
Reports to: Technical Services Department Manager, Plant Manager
Directly Supervises: QA Inspectors, Document Control Officer
Performs quality assurance duties to prevent or eliminate defects in in-process/line or in final inspection operation. The QA Supervisor schedules and reviews in-process auditing of all plant operations. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with PUPC policies and procedures as well as cGMPs.
SPECIFIC DUTIES AND RESPONSIBILITIES
1. Supervise and coordinate activities of associates engaged in inspection and document control related activities to ensure adherence to company quality standards and customer specifications.
2.Establish and report on the performance of the Quality Management System, including that help decision making for targeted actions.
3. Ensure that procedures and specifications are appropriate and followed. Review any document that gives work instructions and set requirements such as procedures, protocols, test
methods and specifications- including changes to these documents.
4. Monitor the production processes and ensure that appropriate in-process controls are performed during manufacturing operations and results are satisfactory. Involvement in decision making to stop production if quality standards are not being met.
5. Document and investigate deviations, and non-conformances. Facilitate, assess, evaluate, and recommend for approval site investigations and CAPA records.
6. Review and recommend for approval/ rejection of reprocessing and rework procedures.
7. Oversee the verification of status stickers issued to operations. Oversees the inspection and AQL sampling of finished products.
8. Review compliance of completed Manufacturing records (batch records, forms, etc.) and quality control records (test/analytical results). Ensure timely closure of records.
9. Oversee sampling of incoming raw/ packaging materials for laboratory testing.
10. Oversee physical testing of packaging material components using validated methods against scientifically derived, fit-purpose specifications.
11. Acts as the Internal Quality Lead Auditor. Create audit program and schedule auditing assignment.
12. Review complaints to determine if it relates to a failure to meet specifications, if to investigate and report to FDA if it is serious and unexpected.
13. Assist in Annual Product Review/Annual Report Compliance.
14. Alternate to sign the final release of the finished product in the absence of Technical Services Manager.
15. Maintain confidentiality of information.
16. Perform other duties which may be assigned by the Technical Services Manager, for which Training and/or an explanation has been provided and understood.
Education and Training : BSc degree in a scientific or technical field preferably in Life sciences, pharmacy or engineering required .
Work Experience Requirements : At least three (3) years experience in Quality Assurance in a pharmaceutical firm, with a minimum of one (1) year in a Supervisory position.
Skill/Knowledge & Other Requirements : Strong working knowledge of cGMP principles.Strong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products. Experience in participating in deviation investigations, determining root cause, and developing corrective action plans.Team player with strong interpersonal, organizational, and communication skills.Good moral character.