QA Manager
On-siteSulaymaniyah, Muḩāfaz̧at al Ḩudaydah, Republic of Yemen
Job Summary
Oversee overall quality control operations by setting objectives, implementing procedures, and managing a team of analysts to ensure compliance with ISO, Pharmacopeia, and GLP requirements. Progress and coordinate all quality and product-related data to enable batch release, while managing validation, change control, and GMP deviations. Supervise QA staff across documentation, compliance, validation, and IPC departments, prepare and revise manufacturing documents, and represent the company in external audits. Lead vendor audits, manage GMP deviations and customer complaints, and implement corrective and preventive actions. Release finished products through the ERP system and approve quality documents including SOPs, specifications, and protocols.
Required Qualifications
- 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
- ensuring regulatory Quality system implementation according to ISO, Pharmacopeia and GLP requirements
- Progress and co-ordinate all Quality related activities and product related data to enable delivery of product to customers
- 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
- Manage supervision and support of the QA staff (Documentation, Compliance, validation & IPC) departments in the day-to-day activities and other routine tasks
- 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
- To ensure completion of actions from external audits and represent the company in external body audits such as MOH or external regulatory
- 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
- To lead external audit and External Audit such as vendor audit
- To escalate and communicate critical issues, advising Senior Management where necessary, and ensuring that actions needed have appropriate priority
- Responsible to release finished product through ERP system
- Approving quality documents (SOPs, MFR, MPR, Spec. MOA, VMP, Protocols, Quality Agreement ...etc.)
- B.Sc. in Chemistry, Pharmacy or Biology or an intermediate institute degree
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.