Operational Quality Officer
- At least Two (02) Years experience in a pharmaceutical environment. Expertise in the field of quality.
- Good knowledge of GMP & EHS and Proven record of attention to detail.
- Good level of English language written & spoken and Good documentation ability.
- Experience of production processes, equipment and systems.
- Good in Computer skills (Microsoft office )
To enable them to evaluate the right requirements of the process to ensure batch document review and product release is in compliance with GMP and regulatory standards.
Similar experience in Saudi Arabia
To Release product that is manufactured and/or packaged in compliance with SFDA, QMS and cGMP requirements and to Ensuring that all operations relevant to quality within the site are undertaken following the appropriate standards.
Describe the key deliverables to be achieved by the post holder and the on going responsibilities of the role
- Review Batch Record Documentation for compliance to cGMP's, SOP's, internal and regulatory requirements. Support the release process to ensure that products released for sale have been manufactured and packaged in accordance with cGMP and applicable laws.
- Perform the achieving and destruction of the batch dossiers and retain sample as per relevant procedure within the lead time.
- Highlight any trending occurring during recording of documentation error to OQ Supervisor.
- Perform the duties in shifts, extended hours and weekends whenever is required.
- Ensure that all the manufacturing and packaging processes are operating within the defined controls as per relevant BMIs, BPIs and SOPs by frequent GEMBA and coaching of production staff to develop their Quality mindset.
- Support production in Quality matter whenever is needed during investigation / issues.
- Communicate to Production, QC, Procurement and Supplier Quality about any issue during the evaluation of packaging/raw material and during manufacturing/packing process in conjunction with manufacturing/packaging staff.
- Allocate item code & barcode once the request is received in timely manner and give priority to urgent issues.
- Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect, Zero Waste and continues improvements.
- Check, archive and destruct the BOMs as per relevant procedure.
- Review BMIs & BPIs and support the priority cases.
- Perform Self Inspection (L1 Audit) in OQ department as per L1 Audit Schedule.
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