Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the formulation and spray drying of pharmaceutical and biotechnology products, providing a complete service from early-stage feasibility through to development and scale-up (including GMP clinical manufacture). Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.
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.
The Role
Upperton Pharma Solutions have a unique and exciting opportunity to join us as a Quality Assurance Manager (Systems) reporting directly to the Director, Quality and Compliance.
The role holder will provide leadership to the Quality Assurance team and be accountable for ensuring that Upperton maintain compliance to current Good Manufacturing Practices (cGMPs) in line with Upperton’s relevant licensed activities (IMPs).
Job Specification
- Ensure compliance with the company quality systems, GMP requirements and all regulatory body requirements
- Responsible for the oversight of the Quality Management system
- Responsible for the internal procedures and processes relating to Risk Management, Material Management, Facility and Equipment Validation – ensuring full compliance across the business.
- Prepare, review and authorise quality documentation within the Quality Management System.
- Monitor and trend any quality aspects pertaining to the facilities/equipment and Quality Management System in line with GMP requirements.
- Plan, direct and, as necessary, conduct internal & external compliance audits of suppliers to assure compliance to company policies and procedures.
- Track and trend quality metrics, analyse trends and identify and assure implementation of improvement initiatives.
- Provide specialist Quality Assurance advice to internal stakeholders.
- Proactively promote a continuous improvement culture within the company.
- Maintain continuous personal development and maintain up to date knowledge with current and proposed pharmaceutical regulations.
The Candidate
- Must have significant experience (5+ years) of working in a Pharmaceutical Quality Assurance role and preferably in a CDMO or CMO.
- Experienced in a range of pharmaceutical dosage forms and it is also desirable to have experience of early phase clinical development (Phase I/II) projects.
- Experience of working independently and as part of a team.
- Excellent written and verbal communication skills
To apply please send a CV to Jon Austwick : Director, Quality & Compliance [email protected]
Closing date for applications: Sunday 5th March 2023 – No agencies please
For more information, please click: https://www.upperton.com/new-job-opportunity-quality-assurance-systems-manager-2/