QUALITY ASSURANCE SUPERVISOR (Pharmaceuticals - Quality Assurance)

الكويت

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.


Skills

Job Requirements

Educational Qualification

  • Bachelor’s degree in science / pharmacy.
  • Certification in Quality Management System (ISO 9001;2015) would be an advantage.

Work Experience & Other Requirements

  • Minimum of 3 – 5 years of experience in the same field.
  • Knowledge on WHO best practices such as GMP / GSP / GDP.

Behavioural Competencies

  • Planning and organizing
  • Delegation
  • Problem analysis and problem solving
  • Decision making
  • Communication skills
  • Interpersonal skills

Language Skills

  • Proficiency in English and Arabic languages.


تاريخ النشر: اليوم
الناشر: Bayt
تاريخ النشر: اليوم
الناشر: Bayt