UK ~ Reading
Head of Quality Assurance and Qualified Person - QP
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to our continued growth and success we have a fantastic opportunity for a Head of Quality Assurance and Qualified Person - QP to join our Quality Assurance group. As the Head of Quality Assurance and Qualified Person - QP you will lead the department, support the training and development of the team and oversee the pharmaceutical quality system. In addition you will be responsible for batch reviews, certification and release of manufactured, assembled or imported investigational medicinal products (IMPs).
Based at our Reading site, you will be working with a multi-functional project team project team therefore you will be required to work effectively and communicate with colleagues across functional areas of the business. Being able to build strong working relationships and to collaborate with colleagues and customers is also important in this role.
Main tasks and responsibilities include:
- Line management of the QA team
- Administration of the Pharmaceutical Quality System
- Oversight of the Product Specification File for individual studies
- Interpretation and communication of GMP regulatory requirements to staff and customers
- Guidance and mentoring of QA and operational staff in GMP requirements and issues
- Review and approval of development protocols and reports[NH1]
- Review and approval of master batch records
- Review and approval of out of specification results/laboratory investigations/Quality Events and deviations
- Assistance with planning, conduct, reporting and follow up of GMP audits (internal and sub-contractor or supplier)
- Involvement in customer, regulatory or other inspections/audits as required
The successful candidate must be eligible to act as a QP for Investigational Medicinal Products as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004. The ideal candidate should also have at least 5 years experiences in a GMP QA role within the pharmaceutical or related industry. Experience working with oral solid dosage forms, including capsules and tablet formulations, inhalation products and non-sterile liquids and suspensions would be beneficial for this role.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.