Product Quality Manager (QP) – Northern Ireland

Naynesh Mistry at CK Science is currently recruiting for a Product Quality Manager (QP) to join a leading pharmaceutical company based in Northern Ireland on a permanent basis.

Responsibilities:

The Product Quality Manager (Qualified Person) will be responsible for QP certification and final batch release of both commercial products and Investigational Medicinal Products (IMPs).

As a Product Quality Manager (QP) you will:

  • Ensure that each batch of commercial product manufactured has been checked for compliance with the Marketing Authorisation or Product licence
  • Support the Product Quality Team to ensure that the unique quality requirements of each product are managed
  • Attend teleconferences/meetings, initiating Qualified Person related discussions for new or ongoing business and offering advice on QP-related queries, as appropriate
  • Represent the Quality Department during customer audits, regulatory inspections and sales visits
  • Review and approve key quality system documentation, such as change requests, deviation reports, out of specification result investigations and customer complaint investigations
  • Ensure that processes are in place to assure highly effective and efficient batch record review in line with customer and Pharma Services expectations
  • Stay current with legislation, guidelines and other expectations of the pharmaceutical industry especially in relation to GMP, Quality Management and IMPs
  • Identify and implement continuous improvement within the department and wider business.

Qualifications:

The successful Product Quality Manager (QP) will have the following qualifications, skills and experiences:

  • BSc or equivalent in science based discipline (Pharmaceutical, Chemistry) or equivalent,
  • QP status achieved under permanent provisions
  • Previous significant experience working within an established Quality System within a Pharmaceutical Industry.
  • Experience in a customer facing role.
  • Good knowledge of legal requirements, rules and guidance covering the manufacture of IMP’s in Europe and the rest of the world.
  • Experience of Solid Dose
  • Experience of supporting QP’s
  • Knowledge of other pharmaceutical dosage forms including sterile products.

How to apply:

To apply for this Product Quality Manager (QP) position contact Naynesh Mistry via email: nmistry@ckscience.co.uk or telephone: 0114 283 9956.  Please quote reference SH26621 in all correspondence.

 

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