Qp

**Company Overview**

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.

**Job Summary**

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 reviews, certification and release of manufactured, assembled or imported investigational medicinal products (IMPs).

Based at our Reading site, 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**:

- Oversight of the Product Specification File for individual studies
- Interpretation and communication of GMP regulatory requirements to staff and customers
- Guidance and mentoring to QA and operational staff in GMP requirements and issues
- Review and approval of development protocols and reports
- 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
- 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.
- Have the ability to travel regularly to Quotient’s site in Reading, with home working options.
- 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.

**Company Benefits**

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.