QA Officer |Location : Nottingham UK | Type : Full time, permanent
Upperton Pharma Solutions is a contract development and manufacturing organisation (CDMO) that specialises in the development and production of novel pharmaceutical drug products for use in clinical trials. Our clients come from across the globe, seeking to utilise our specialist knowledge and experience in the development of a wide range of challenging pharmaceutical formulations that are used to treat indications as diverse as oncology, diabetes and cardiovascular disease.
The Upperton laboratories and manufacturing plant are situated on the Science Park, adjacent to the University of Nottingham, and since obtaining an MHRA clinical trials manufacturing licence in 2019 we have experienced rapid, continuous growth across the whole business to continually satisfy our growing, international customer base.
As part of this expansion programme Upperton is now looking to recruit highly motivated individuals to join our scientific team. In all roles, scientists work on client projects ensuring high-quality of activities to meet project goals and milestones.
This is a great opportunity to join our Quality Assurance (QA) team as a QA Officer. In this role the successful candidate will need to ensure that all of our operations are compliant with internal procedures and regulatory requirements. You will also support in the provision and development of an efficient and effective QA department.
Tasks and Responsibilities:
- Writing, reviewing and approving SOPs
- Writing of Quality technical agreements
- Review and approval of analytical and manufacturing documentation prior to QP certification
- Participation in the change control process to ensure changes to processes, systems, equipment and facilities are appropriately assessed and implemented
- Involvement in supporting sponsor GMP audits, co-ordination of responses and follow up of corrective and preventative actions
- Involvement in quality issue investigations and agreeing CAPAs
- Support the development and implementation of the company quality system as required
- Interpretation and communication of information (e.g. GMP requirements) and provision of advice on quality issues to members of staff and clients
- Review and approval of validation activities such as equipment and computer systems validations
- Involvement in regulatory inspections and sponsor audits as required
- Review of analytical protocols, results and investigations, ensuring data integrity
- Performing audits to monitor compliance of internal operations with internal procedures and regulatory requirements
This role requires you to work effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships..
- Ideally from a Pharmaceutical Quality Assurance background
- Experience of working within a GMP environment
- Science based degree preferred but willing to consider other equivalent training or vocational experience
- Good Computer literacy, high attention to detail and accuracy
- Exposure to pharmaceutical manufacturing would be an advantage.
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.
To apply please send a cover letter and CV to email@example.com.
Please specify in your cover letter which position you are interested in :- QA Officer
No agencies please.
Closing date for applications: Sunday 10th October 2021