Senior Quality Assurance Officer
Location : Nottingham UK | Type : Full time, permanent
Senior Quality Assurance Officer (Permanent)
Upperton Pharma Solutions is a pharmaceutical company based at the Science and Technology Park close to Nottingham University. Due to continuing expansion, an exciting opportunity has arisen for a Senior Quality Assurance Officer.
This is a senior QA position and the personnel holding this role are expected to have excellent communication skills and a good understanding of cGMP.
It will be expected that the personnel in this role will be self-driven and capable of managing their time effectively. They will be expected to take a proactive approach in providing QA support and advice to the other areas of the business.
The role will have a combination of customer facing, supplier facing and internal stakeholder responsibilities and will require good communication skills.
The role will work closely with the Operations and Project management teams along with contracted microbiology testing facilities / service providers.
• Very Good Communication skills and experience of demonstratable experience of working as part of cross functional teams.
• Being the lead QA representative supporting project meetings which will include customer facing activities where required.
• Advising staff on GMP aspects and provide QA support in formulation, manufacturing and analytical investigations.
• Review manufacturing, analytical data, deviations, CAPA’s and change controls associated with the release of investigational medicinal products.
• To assist in client and regulatory audits as required
• Ensure the Pharmaceutical Quality System (PQS) is maintained in accordance with regulatory requirements.
• Proactively lead and engage in continuous improvement activities particularly associated with Good Manufacturing Practice.
• Perform raw material release activities.
• Document author for Quality related documents
• Responsibility for leading quality related investigations related to deviations and CAPA’s
• Responsibility for providing QA support and training in how to complete quality related documentation e.g. change controls, deviations and CAPA’s.
• Responsibility for ensuring QA system related responsibilities are performed on time e.g. self inspections, mock recalls, training, and supplier approvals.
• Providing quality data for presentation in the management review.
• Supporting the audit of external material suppliers and service providers.
• Liaising with material suppliers and service providers to obtain information to support clinical batch release
To apply, please send a CV and covering letter to email@example.com
Closing date for applications: 10th December 2022