Reference Number: JO-2003-448433
RP – Quality Manager
Job Type: Permanent
RESPONSIBLE PERSON/QUALITY MANAGER
Location: Cambridge, UK (Partial remote working option)
Salary: Negotiable dependent on experience and excellent benefits package
Our client, a long established, well respected Pharmaceutical business is looking to recruit a talented, highly experienced Quality Assurance specialist to undertake full responsibility for the Distribution Quality function. You will need to be a GDP Quality Specialist with significant experience gained in a Responsible Person role within Pharmaceuticals distribution.
As the Responsible Person/Quality Manager, responsibilities will include (but not be limited to):
Acting as Responsible Person on the company Wholesale Distribution Authorisation by:
Ensuring the company is operating within the conditions of the WDA;
Maintaining the quality management system;
Ensuring that operations do not compromise the quality of medicines, and that records are accurate and complete;
Ensuring that initial and continuous training programmes are implemented and maintained for all staff;
Maintaining oversight of changes made or proposed through the company change control system;
Coordinating and promptly performing any recall operations for medicinal products alongside the technical operations and production Quality Assurance functions;
Ensuring that relevant customer complaints are dealt with effectively;
Ensuring that suppliers and customers are approved;
Approving any subcontracted activities which may impact on GDP;
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
Keeping appropriate records of any delegated duties;
Deciding on the final disposition of returned, rejected, recalled or falsified products;
Ensuring appropriate standards of GDP are maintained;
Approving any returns to saleable stock;
Ensuring that any additional requirements imposed on certain products by national law are adhered to.
Communicating and escalating emerging Quality risks to all relevant stakeholders as appropriate.
Conducting a regular effectiveness review of the Quality System and present to the Leadership Team on a quarterly basis.
Overseeing the maintenance of the Wholesale Distribution Authorisations to ensure they continue to appropriately reflect the companys activities.
Responsible for the preparation, review and approval of technical and quality agreements.
Hosting and coordinating GDP inspections by the MHRA.
Educated to degree level (Bachelors or Masters) in a relevant discipline.
Possesses comprehensive knowledge of GDP and relevant regulations, along with experience as a nominated Responsible Person, in line with the requirements specified in the MHRA Notes for applicants and holders of a Wholesale Dealers Licence (WDA(H)) or Broker Registration.
A self-starter, demonstrating accountability for their own output and a strong sense of ownership for their projects, as well as the ability to define and manage multiple priorities.
Proven ability to build relationships and inspire confidence and respect at all levels; excellent team player.
Possesses outstanding communication skills.
Ability to build rapport and demonstrate strong influencing and negotiation skills.
Excellent listening ability receptive to feedback and demonstrates flexibility, curiosity and an ability to learn.
Able to demonstrate all elements of the Cogent Gold Standard for the Responsible Person.
This role represents an outstanding opportunity for a highly experienced Quality Manager/Responsible Person to take a highly visible and autonomous role within the business and to take full ownership of the GDP Quality Assurance Process/function.
If you are interested in this opportunity please call Jim Maddison at Scientific Professionals on 0044 (0)7500 962378 or send an updated version of your CV via email to firstname.lastname@example.org
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