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.
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.
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: firstname.lastname@example.org or telephone: 0114 283 9956. Please quote reference SH26621 in all correspondence.