Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast
Due to our continued growth and success we have a fantastic opportunity for a Qualified Person (QP) to join our Quality Assurance group. As the QP you will be responsible for batch certification and release of manufactured, assembled or imported investigational medicinal products (IMPs)
Based at our Alnwick site which has recently had a £6 million investment in the drug manufacturing facility , with flexible working arrangements, you will be working with a multifunctional 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
- Batch certification and release of investigational medicinal products and bulk API
- Approval of shelf life extensions
- Collaborate with the QA Operations team on the review and approval of pharmaceutical development protocols and reports, batch records, out of specification results/ laboratory investigations/ quality events and deviations
- Review and approve Quality Agreements
- Review and approve specifications, certificates of analysis and stability reports
- Review drug product sections of Investigational Medicinal Product Dossiers
- Maintenance of the Product Specification File for individual studies
- Involvement in study team meetings, discussions, etc as required
- Manage the planning, conduct, reporting and follow up of supplier and external laboratory audits
- Involvement in customer, regulatory or other inspections/audits as required
- Involvement in customer meetings as required
- Liaise with QP’s at other Quotient sciences sites and contract QP’s as required
- To comply & adhere to GXP guidelines and regulations as required of this role
The ideal candidate will:
- Be eligible to act as a QP for Investigational Medicinal Products as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004/1031 as amended
- Minimum 5 years experience in a GMP QA role within the pharmaceutical or related industries
- Have the ability to travel regularly to Quotient’s site in Alnwick, with home working options
- Experience working with sterile and non-sterile liquids and suspensions, oral solid dosage forms, including capsules and tablet formulations, inhalation products would be beneficial for this role
In return, you will receive a competitive salary, benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.