Job description:
Job purpose:
To review and approve all documents related to Quality Assurance functions : change controls, deviations, CAPA and annual product review reports while overseeing and reviewing GMP areas processes and procedures to make recommendations for changes and/or improvements.
Key responsibilities:
Recommends improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Quality activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost- effective service to customers.
Supervises the day-to-day operations of Quality section to ensure that work processes are implemented as designed and comply with established policies, processes and procedures.
Reviews and approves documents generated by the department, in order to provide approvals on deviations, Complaints, CAPA, and annual product review reports.
Participates in quality risk management procedures, in order to manage and maintain the day-to-day change control process for product and process related information.
Manages the creation and revision of batch record documents to support product development and product implementation.
Oversight on the projects including new facility planning and construction of compounding equipment/facilities and system/process improvements to modify and optimize new product/process material qualifications.
Participates in developing divisional procedures and guidelines to develop responses to corporate, regulatory, and third-party audits findings.
Interacts with all plant departments to facilitate effective change control execution in order to meet the 2 Confidential anticipated timelines.
Utilizes data from QA Trending for Deviations, CAPA, and Risk Assessment to identify and escalate Product Quality risk and monitor QA metrics as appropriate.
Develops the Compliance (FDA six systems) function’s work plan and monitors workflow by reviewing and evaluating work methods and procedures to serve the department’s goals and plans.
Conducts gap analysis for Hikma functions actual and potential performance to facilitate harmonizing the system within the group.
Notify production, planning and operations management of all rejects or Non-conforming products.
Final release for product according to cGMP guidelines and authorities requirements
Qualifications & Experience:
Minimum Qualifications:
Bachelor’s degree in Pharmacy, Chemical Engineering, or equivalent with a master’s preferred.
Minimum Experience:
8-10 years relevant experience in pharmaceutical industry including at least 4-6 years in a Quality/Compliance role.
At least 2 years of experience in a progressive managerial role.
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