QA Manager

• Job Profile/ Summary:

(Briefly, summarize your job)

1. The duties assigned to this job could be summarized in: QA Manager oversees the overall quality control operations within the company. They are responsible for setting quality objectives, developing and implementing quality control procedures, managing a team of analysts, and ensuring regulatory

1. Quality system implementation according to ISO, Pharmacopeia and GLP requirements.

• Job Responsibilities & Authorities:

1. Freedom to act / Job Scope:

(The potential impact an individual job holder may have on the entire organization)

1. Progress and co-ordinate all Quality related activities and product related data to enable delivery of product to customers.
2. To understand all required information to enable the release of batches, including validation, change control and GMP deviations and to ensure that these are effectively managed within the QA activities.
3. Manage supervision and support of the QA staff (Documentation, Compliance, validation & IPC) departments in the day-to-day activities and other routine tasks.
4. To work with others to ensure that product related documentation is Prepared, revised and available when needed. This will include batch Manufacturing and packaging documents, specifications, bill of materials, SOPs and Validation documents.
5. To ensure completion of actions from external audits and represent the company in external body audits such as MOH or external regulatory.
6. To manage GMP deviations, incident reports and other exception events and customer complaints; to identify common issues, trends and propose improvements and to ensure that corrective and preventive actions are implemented and are effective.
7. To lead external audit and External Audit such as vendor audit.
8. To escalate and communicate critical issues, advising Senior Management where necessary, and ensuring that actions needed have appropriate priority.
9. Responsible to release finished product through ERP system.
10. Approving quality documents (SOPs, MFR, MPR, Spec. MOA, VMP, Protocols, Quality Agreement ...etc.)

• Education & Experience:

1. 6.1- B.Sc. in Chemistry, Pharmacy or Biology or an intermediate institute degree.

1. Minimum 8 years Have worked in generic pharmaceutical factories.

And in oncology factories (finished formulation) for at least 5 years

Good background in basic chemistry, biology and theory of analytical techniques.