QUALITY ASSURANCE SUPERVISOR (Pharmaceuticals - Quality Assurance)

Job Purpose

Responsible for supervising the implementation of all Quality Assurance (QA) related activities, and ensuring

the adherence of the same to Mohamed Naser Al – Hajery & Sons Policies and Procedures and QA leading

practices.

Key Roles and Responsibilities

Policies & Procedures

• Monitor the implementation of the Quality Assurance established policies and procedures and comply with Mohamed Naser Al – Hajery & Sons other policies.
• Administer prompt, fair and consistent corrective action for all violations of company policies, rules and procedures in coordination with Superior.

Quality Assurance Supervisor Responsibilities

• Ensure Quality Assurance systems and procedures are in place, including but not limited to:
• Compliance to International Pharmaceutical Standards.
• International Quality Standards (such as GSP, GDP, GMP requirements of WHO)
• MNH Supplier Quality Standards (as established through Technical Agreements)
• Regulatory requirements.
• Approve incoming goods by ensuring goods received are checked for quality (i.e. including physical
• temperature, etc.) against quality parameters set by the organization.
• Monitor proper storage of products for safety as well as ensure damage / expiry / non-saleable products are stored separately from saleable products.
• Ensure the thermal mapping is done for the warehouse. Review and retain the thermal mapping documents.
• Ensure periodic calibration of temperature reading devices to ensure the calibration certificate is valid.
• Monitor movement of products to and from the warehouse are under prescribed temperature norms and following product-handling procedure as specified by the supplier / MNH SOPs.
• Monitor temperature of warehouse (including chiller rooms) and distribution vehicles are within the
• range. Download the temperature reading reports from the system and maintain for records.
• Review the action taken in case of temperature deviation (in warehouse as well as during transit) and advise warehouse management further action, if any to prevent deviations in future.
• For products under damage / destruction / recall, ensure procedures as per Quality SOPs are followed and goods are stored in separate place demarcated for the purpose.
• Monitor access control to different locations of the pharmaceutical warehouse (i.e. main entrance,
• area, damage / expiry stock area, etc.).
• Monitor cleaning and maintenance of pharmaceutical warehouse (including receiving, quarantine,
• area, etc.).
• Monitor pest control activities in the pharmaceutical warehouse.
• Monitor maintenance and safety of equipment used in the Pharmaceutical warehouse.
• Ensure Change Control documents are prepared and authorized for any significant changes done to the Warehouse (including process, physical location, etc.) that may have impact on the product quality.
• Ensure fire and safety SOPs are followed by conducting training for the warehouse personnel, performing fire drill, etc.
• Prepare annual training plan and obtain approval from the Warehouse Manager.
• Train the relevant personnel of the warehouse on the implementation of Quality SOPs as per the training plan.
• Maintain all necessary documents (forms / formats / Agreements, etc.) that are necessary to ensure effectiveness of the quality management function.
• Perform Self Inspection as per the Self-Inspection Calendar and discuss the results with Warehouse
• with action plans. Monitor the action plans to ensure the same are implemented within the agreed time.
• Assist in the creation, review, revision, and management of standard control documents (include quality work instructions).
• Monitor the implementation of the approved SOP in co-ordination with Warehouse Management.
• Maintain risk registers and following up with the relevant management for implementation of mitigation measures.
• Maintain effective communication with the supplier quality control function.
• Handle supplier audits along with Warehouse Management.

Miscellaneous Duties

• Perform other duties related to the job as assigned by the Direct Manager.