Q.A Manager

Responsibilities:

1. Responsible to maintain a satisfactory and good environment in between production, warehouse, maintenance and marketing according to the GMP and GLP.
2. Manage the smooth working and technical activities in Q.C.
3. Authorized to release or reject the Raw Material, Packaging Material, In-process Product for further processing and finished product on valid grounds.
4. Review and monitor the objectives on a regular basis and revise whenever needed.
5. Evaluate the Laboratory and ensure that it is capable of doing the tests as per specifications and standards.
6. Responsible for all purchases made in the laboratory, raising requisitions containing the specifications of reagents, equipment, glassware, chemicals, and microbiological articles.
7. Ensure that bulk samples of chemicals and glassware are stored by the material management department under conditions agreed and verified by QCM.
8. Responsible for evaluation and approval of suppliers and vendors.
9. Assign complaints to the Laboratory staff for investigation of root causes and propose corrective actions.
10. Ensure competent and authorized persons for operational work of equipment, performance, and calibration.
11. Authorize activities based on evaluation, experience, training, and satisfactory knowledge of testing, equipment, and calibration.
12. Prepare job descriptions for each member of the laboratory.
13. Ensure all facilities required to perform tests in standard manners are available, including energy resources, weighing, and environmental conditions.
14. Review all environmental monitoring records on a monthly basis.
15. Ensure appropriate SOPs are available for all tests performed under the scope of accreditation.
16. Ensure that open hand instruments for all equipment are available in the laboratory and appropriate personnel are trained.
17. Ensure that correct data is being transferred from raw data to final reports.
18. Ensure that reference materials are certified against traceable certificates and standards; internal standards used are validated before use.
19. Any amendments in test reports, calibration dates, and other QC related documents can only be executed after the approvals of QCM.
20. All SOPs and methods must be prepared and approved.
21. Enforce GMP compliance in production QC and warehouses.
22. Responsible for all documents such as IQ, OQ, PQ, validation, and stability records.
23. Supervise the maintenance of monthly log registers for Raw, Finished, Packaging, and stability records.
24. Supervise the inventories and consumption records of reagents and glassware.

Knowledge:

1. Documentation, Clerical - Knowledge of administrative and clerical procedures and systems.
2. Chemistry - Knowledge of the chemical composition, structure, and properties of substances.
3. Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
4. Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and techniques for maximizing effective manufacture and distribution of goods.
5. Medicine - Knowledge of information and techniques needed to diagnose and treat human injuries, diseases, and deformities.

Quality Management: Focused on both quality assurance and control of processes to assure qualitative products and methods to achieve it.

Skills:

1. Critical Thinking - Using logic and reasoning to identify strengths and weaknesses of alternative solutions.
2. Monitoring - Assessing self-performance, other individuals, or organizations to make improvements.
3. Systems Analysis - Determining how a system should work and how changes will affect outcomes.
4. Systems Evaluation - Identifying measures of system performance and actions needed to improve performance.

Location: Information Technology and Services - Karachi, Pakistan