Operational Quality Supervisor
- At least Five (08) Years experience in a pharmaceutical environment and minimum 2 years in supervisory role.
- Expertise in the field of quality.
- Excellent knowledge of GMP & EHS.
- Excellent level of English language. [Written & Spoken]
- Experience of production processes, equipment and systems.
- Good documentation ability.
- Competency level – Competent.
- Good in Computer skills (Microsoft office )
Similar experience in Saudi Arabia
To supervise Operational Quality activities such as batch release, OQ oversight of production & testing related activities and GMP investigation to ensure compliance with SFDA guidelines, relevant local standard operating procedures, QMS requirements and prevalent cGMP standards.
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- Responsible for review of all completed Batch Dossier record of each product manufactured / packed by Glaxo Saudi Arabia Ltd. prior to the release of the products to market.
- Supervision of the QA random in-process checks at various stages of the manufacturing and packaging as and when required.
- Responsible for update of the Bar Code, Item code for the products and as well as for the Packaging components in the Item code Bar code system.
- Involved in the Investigation of GMP deviations for handling and maintaining the record of investigation of the GMP deviations.
- Involved in the investigations of the product complaints related to GSAL site to ensure all complaints are recorded, investigated and reviewed properly.
- Responsible for preparing / revising SOPs of OQ department to align with SFDA guidelines, QMS requirements and cGMP practices.
- Responsible for Supplier Deviation handling, investigation and ensuring those CAPAs are tracked and closed in timely manner.
- Responsible for provide Data for Zero Defect on weekly and monthly basis.
- Responsible to review and compliance check of BMIs, BPIs, of all products pertaining to the production.
- Support Production in quality matter to ensure that all the processes are operating within defined control as per relevant documents (BMI, BPI & SOPs)
- Involve in problem solving to resolve the quality issues quickly to support Zero waste.
- Responsible for maintaining the electronic record and hard copies for Site Deviation, Supplier Deviation and Customer Complaint.
- Involved in raising ZAPs and initiatives to ensure EHS standard are maintained in OQ department.
- Perform L1 Audit of OQ department as per Departmental Audit Universe and supervise the completion of CAPAs on time.
- Supervise the OQ governance in shift, extended hours and holidays and or whenever is required.
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