Life Sciences

Qualified Person

£80k - £90k per annum

South East England

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About the role:

A leading pharmaceuticals business based in the South East are looking to hire a Qualified Person to support the batch release process of sterile and biologics products that are developed and manufactured on-site.

This role would be a great step for either an experienced QP who is looking to gain experience in biologics, or a more junior eligible QP with a sterile/biologics batch release support background who is looking for a traditional QP role.

As Qualified Person you will be an active member of the Quality Assurance batch release team and be the subject matter expert for your area that will span a broad range of projects, processes, and drug products. You would hold specific oversight and responsibilities for key quality systems and processes and will also serve as a primary quality partner for other key functional areas. You will also support with project specific activity, including continuous improvement and operational excellence initiatives.

As Qualified Person, you will be responsible for:

  • Final disposition and certification to ensure that the batch has been manufactured in accordance with the requirements of the Marketing Authorisation and guidelines of cGMP.
  • Providing overall quality direction and oversight for key functional areas such as Process Development, Validation, Quality Control, Supply Chain and Engineering.
  • Co-ordinating and approving Product Quality Reviews including batch listing and deviation trend reports.
  • Quality SME review and approval for regulatory submissions to ensure compliance with site and corporate procedures.
  • Quality Risk Management
  • Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required
  • Inspection readiness activities and hosting of internal and external audits/inspections
  • Participation in self-inspection program in a lead auditor or auditor capacity
  • Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums
  • Provision of Quality Oversight and partnership for internal and external customers
  • Assuming site or business process owner roles and active participation at network meetings and external forums

If you have the following experience, you could be a great fit:

  • Technical skills and demonstrated competencies across a broad range of quality related disciplines.
  • Relevant experience working in the pharmaceutical or biotechnology industry in Quality Assurance
  • Must satisfy the requirements as outlined in Directive 2001/83/EC to act as a Qualified Person
  • Educated to degree level in a Scientific or related discipline

A salary of £80,000 – £90,000 is on offer dependent on the level of prior experience with an excellent benefits package and flexible working.

This position is a critical hire to support business growth so interviews will begin early in December. If you are considering a move and this looks like it could right next step, then please apply as soon as possible to be considered for interview.

If you have any questions prior to applying, then you can also contact James Ivall at Goodman Masson to discuss further.

Hope to hear from you soon.

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Sounds good?

Does this role sound like the right for for you? Apply using the form and one of the Goodman Masson team members will get back to you as soon as possible. Good luck!

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