Head of Quality QP RP

Location
Cambridge
Salary
£80000 to £100000 per annum
Posted
02 May 2019
Closes
30 May 2019
Ref
J5631247
Contact
Chris Carey
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Head of Quality and QP/RP to join a leading Pharmaceutical company based in the Cambridge area. As the Head of Quality and QP/RP you will have direct responsibility for all Quality Activities across the business, driving the Quality first Culture and ensuring compliance against regulations and maintenance of Product Licenses.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Head of Quality and QP/RP will be varied however the key duties and responsibilities are as follows:

1. You will take responsibility for ensuring compliance to regulatory standards, including GMP, GDP and ISO certifications for the company. You will be the first point of contact with regards to all Quality Related Issues (CAPA, Change Control, Investigations, Internal/External Audits) and take the lead on Quality Projects, as well as maintain awareness of all relevant legislation (MHRA/FDA/Eudralex).

2. As the Head of Quality and RP, you will take full ownership of the development and maintenance of company wide Quality Systems. (QMS), and Quality Strategy. This will include scheduling and managing audit plans, managing the CAPA process, arranging and chairing QMS reviews as well as working with the senior leadership team from other sites advising on Quality issues.

3. You will be named as the Qualified Person(QP)/Responsible Person (RP) for the business and will need to ensure that they are complying with the Good Manufacturing/ Good Distribution Practice GMP/GDP guidelines. This will involve interacting with the companies supply chain network ensuring third party activities maintain GMP compliance.

4. It will be your responsibility to help support the business in their wider activities (Regulatory, CMC Business Development, Clinical), and effectively maintain various product licenses. You will lead train and develop the QA Team with the aim of improving the QA teams operational performance, you will also draft new SOP's to ensure compliance is met while remaining fit for purpose operationally and commercially.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Head of Quality and QP/RP we are looking to identify the following on your profile and past history:

1. You will be recognised as a Qualified Person/Responsible Person or have extensive (+5 years) previous QA Experience within a Manufactuing/Distribution setting.

2. You will have previous experience managing a Quality Assurance team. This will be within a GMDP regulated environment.

Key Words: Quality Manager | Distribution | Quality Assurance | QA | QA Manager | GMP | GDP | GDP | Responsible Person | Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate| Quality | GDP | Good Distribution Practice | Vendor Assurance | GXP | GLP | Compliance | Documentation | QA Officer | Senior QA Officer | QA Associate | Head of Quality | QA Director | Senior QA Manager | Operational | Qualified Person | QP | QP/RP | SOP |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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