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 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.
This is a great opportunity to join our Quality Assurance (QA) team as a QA Associate based at our Reading site. In this role the successful candidate will need to ensure that all operations are compliant with internal procedures and regulatory requirements. You will also support in the provision and development of efficient and effective QA.
Tasks and Responsibilities:
- To ensure compliance with GMP and regulatory requirements.
- To ensure that the Quality Management System is operating efficiently and is in compliance with regulatory guidance.
- To make sure review of quality docs including SOPs, Quality technical agreements, risk assessments, batch records, Change control and etc.as per company procedures
- Review and approval of validation activities such as equipment and computer systems validations
- Review and approval of analytical documents
- Manage and help in planning, execution and monitoring of projects based on company needs.
- Employ the principle of continuous improvement as a basis for teamwork in day-to-day activities with colleagues
- Help and guide others in the company in a collaborative partnership to complete and deliver quality projects.
- Maintain technical awareness by regular review of literature and training courses.
- Actively participate in all departmental and interdepartmental meetings when required.
- Manage assigned work within QA including management of CAPAs, Investigations, LIRs, Deviations, Planned Deviations, Risk Assessments, etc. in a timely manner.
- Support external and internal audits including regulatory inspections
- Engage with QPs, auditors and other scientific and manufacturing staff in a productive manner to make use of their expertise to support quality functions.
- Effectively manage multiple conflicting or simultaneous priorities.
- Flexibility to take on other cross functional responsibilities based on company needs.
- This role requires you to work effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships. You will be required to give information in a clear, concise and timely manner and often use negotiation and consultation skills to resolve complex issues.
- Ideally from a Pharmaceutical Quality Assurance background with extensive experience
- Excellent interpersonal and communication skills
- Excellent organisational, problem solving and follow up skills
- Minimum degree in relevant science
- GMP working experience
- Current compliance knowledge.
- Can do attitude backed by collaborative approach.
- Ability to multi task- handle a large number of activities simultaneously.
- Ability to liaise with colleagues at all levels, plus client and external parties in professional manner.
- Capable of impendent management of projects.
- Avid attention to detail, ability to dissect procedural flaws.
- Well motivated with the capacity to work under pressure.
- Possesses a developed quality, regulatory, and production business mind-set.
Candidate must be eligible to work in the UK.
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.
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.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at Quotient Sciences