Quality Assurance Officer

2 weeks ago

Feltham, Greater London, United Kingdom Bolloré Full time

To ensure that our Healthcare Quality Management System and processes are fully maintained in all areas and that it is robust and effective.

  • To achieve full compliance with the responsibilities of our licences and regulatory requirements and obligations i.e.
MHRA, GDP, API.

  • Produce and maintain documents in our electronic Quality Management System (eQMS)
  • Update documents at set intervals or through required change. Documents include the Quality Manual, Standard Operating Procedures, Forms and Works Instructions
  • Participate in various activities, including via eQMS, related to the QMS including:
  • New client evaluation, approval and progression to agreements
  • Maintain record keeping and report provision in a timely manner
  • New thirdparty suppliers to be correctly appointed through evaluation, review, audit processes and correctly documented. Suppliers include, transport providers, pest control, packaging suppliers, equipment providers, calibration and system providers
  • Working with various suppliers and internally to ensure compliance with set requirements i.e. maintenance of equipment and calibration and equipment providers, at regular intervals
  • Monitor Healthcare training for all involved staff to ensure that training is completed in accordance with required guidelines. i.e. GDP and falsified medicines, plus relevant SOP's
  • Conduct QMS selfinspection auditing to the level mentioned in the SOP as well as adhering to quality and management review requirements
  • Respond and work closely with others regarding deviations, complaints, CAPA, change controls.
  • Monitor retraining and effectiveness
  • Lead Customer Audits
  • Regulatory Audits
  • Work closely with Head of QHSE and Compliance / Healthcare Product manager and other key stake holders
  • Participate in audits and meetings as required
  • Promote and support EQMS for continued benefits throughout the organisation
  • Provide support and guidance to all interested parties, including Healthcare Product, Customer Services, physical Operations, Commercial, Health and Safety, Management and licence holder
  • Any other delegated tasks as deemed reasonable as assigned by your line manager
  • The RP shall ensure there is a training program implemented for all personnel working under the GDP system.
  • The RP shall ensure both suppliers and customers (to whom medicinal products are supplied) are regularly evaluated and approved by a suitable qualification program.
  • The RP is authorised to decide on the final disposition of returned, recalled, reject or falsified products.
  • The RP is authorised to decide that returned products can be included in saleable stock again, after a suitable documented evaluation.
  • The RP shall perform recall operations and shall ensure the recall process is functioning well in case its use is needed.
  • The RP shall ensure that complaints reported at the WDA holder are handled appropriately and reported to the involved MIA holder as soon as possible. The RP shall function as first point of contact for the complainant.
  • Ensure that all provisions of the WDA license are observed.
  • Ensure that that the healthcare product remains compliant with all relevant regulations
  • Udnertake audits of facilities to ensure compliance
  • To report on a monthly basis

Skills & Qualifications

  • Excellent levels of customer service and standards of written documentation
  • Maths and written English of an excellent standard.
  • GDP training (Preferred but not essential)
  • Experience and understanding of Good Distribution Practice (GDP) within Healthcare, or from a pharma quality related background preferred
  • Experience of working with Pharma / Healthcare products or in a quality driven environment preferred
  • An understanding of transportation, including temperaturecontrolled products i.e. Airfreight and both UK / European road transport preferred
  • Compliance, planning, evaluation and working to deadlines
  • Excellent communication skills, both verbal & written
  • Good time management skills, enthusiasm & flexibility
  • Competent in both word and excel.

Benefits:

  • Company pension

Schedule:

  • Monday to Friday

Work Location:
In person

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