Qualified Person - Hertfordshire
Jason Johal at CK Science is currently recruiting for a Qualified Person (QP) to join a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and animal health products. This role is offered on a full time permanent basis.
Due to an increased demand at their UK Headquarters in Hertfordshire, they are looking for a QP to join the Quality Team supporting Clinical Trial Supplies. The team are responsible for the release of API, bulk pharmaceutical products as well as packaged supplies for clinical trials.
Your main responsibilities in this role will be to:
- Review and certify the production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements
- Complete audits of data, information, procedures, facilities, equipment and systems (including computer systems) to ensure compliance to SOPs, GMPs and applicable regulations
- Manage Quality Management Systems covering Investigations, Change Control and Complaints
- Support external auditing of vendors and suppliers will also be required, as well as the generation, review and approval of Technical & Quality Agreements
- Identify compliance gaps, make and facilitate implementing recommendations for continuous improvement
You are required to have the following qualifications, skills and experience:
- Qualified Person eligibility under the permanent provisions
- Ideally experience in Investigational Medicinal Products (IMP)
- Excellent working knowledge of current ICH, EU and US regulatory requirements and their implementation
- Experience in global quality management systems
- Current cGMP knowledge as well as having a good understanding of GCP and the ability to support the Clinical teams across the company
- A Degree or equivalent (or higher qualification) in a scientific discipline such as Pharmacy, Chemistry, Biological Sciences
If you are successful you will be joining a company that believes employees are the key to the company's success. They demonstrate their commitment to their employees by offering a competitive and valuable rewards program. Benefits are designed to support the wide range of goals, needs and lifestyles of their employees, and many of the people that matter the most in their lives.
For more information or to apply for this Qualified Person position please contact Jason on +44 (0)1438 723 500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST31856 in all correspondence.