Qualified Person

Posted 20 February by Crunchposter Limited

Qualified Person
Competitive salary DOE

Monday to Thursday; 9:00 – 5:30
Friday; 9:00 – 5:00

Our client is a leading manufacturer, wholesaler and exporter of branded generic medicines and healthcare products worldwide. They are proud to be a key manufacturer of medicines, supplying to the NHS, retail pharmacy sector and international markets, as well as being the UK’s trusted supplier to Aid agencies and NGOs.

As a company, our client has made a lasting commitment to patient safety, introducing new products to their portfolio whilst maintaining unrivalled quality and exceptional service to the pharmaceutical industry.

The Role
They are currently looking to recruit a Qualified Person (QP) to work with the Quality Assurance Unit Manager (QAU Manager) and their existing Quality Assurance Unit (QAU). As a Qualified Person, you will be responsible for the following:

  • Perform the duties of a Qualified Persons in accordance with the provision of Directive 2001/EC/ EU Guidance on GMP, Annex 16 requirements.
  • Provide support on site improvements and issues; and provide subject matter expert reports as required.
  • Conduct Annual Product Reviews and document license applications and variations.
  • Involvement in New Product Introduction through to product release, including batch certification such as GMP declarations.
  • To work in tandem with the QAU Manager to ensure that that the Quality Management System (QMS) is maintained and operated in full compliance with all the current legislative requirements i.e. GMP, ISO and Medical Devices Directives.
  • To support and conduct all audits (regulatory/ client), prepare and respond with Corrective Action Preventive Actions (CAPA) and close out the same. In addition to this, support internal audits from planning through to closure of actions.
  • Continually monitor and maintain an awareness of GMP/ GDP / ISO requirements to assess their impact on the operations and ensure compliance within a timely manner.
  • Accountability for the liaison between departments in respect of documentation and procedures, problem resolution and conducting investigations associated with deviations, complaints and non-conformances.
  • Liaise with Contract Manufacturing Organisations (CMO) and Packaging Manufacturers with particular respect to suitability of report detail, deficiency clarification and suitability of auditors; and acceptance of proposed corrective actions.

The Candidate
The ideal candidate for the Qualified Person role will portray the following skills and attributes:

Essential Criteria:

  • Qualified QP eligible to release batches within the UK.
  • Substantial proven experience as a Qualified Person within the Pharmaceutical industry.
  • Experience working within an environment with great technical depth and challenge.
  • Experience of involvement across all departments, working at a senior level.
  • Excellent working knowledge of Good Manufacturing Practice and Good Distribution Practice.
  • Excellent communication skills, both verbal and written.
  • Excellent organisational and time management skills.

Qualified Person Benefits
Our client offers a competitive pay package alongside other company benefits such as a pension scheme, private healthcare and annual discretionary bonuses.

If you feel you are suitable for the Qualified Person role, please apply now!

Quality Assurance Specialist, Quality Manager, Pharmaceutical Specialist

Reference: 34518892

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