QA Manager – Systems in Nottingham

Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled. Continued growth and investment into the business has led to the creation of exciting new job opportunities in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.

Reporting to the Quality Director, the role holder will provide leadership to the Quality Assurance team and be accountable for ensuring that Upperton maintains compliance to current Good Manufacturing Practices (cGMPs) in line with Upperton’s relevant licensed activities (IMPs).

Main duties and responsibilities:

• 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 – report findings at the Monthly Management Review meetings.
• Responsible for GMP training for all staff.
• Plan, direct and, as necessary, conduct internal & external compliance audits of suppliers to assure compliance with 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 keep up to date knowledge with current and proposed pharmaceutical regulations.

Essential Skills and experience:

• Extensive experience working in Quality Assurance on a pharmaceutical manufacturing site with demonstrable leadership responsibilities.
• Experience in a range of pharmaceutical dosage forms and early-phase clinical development (Phase I/II) projects.
• Experienced in batch record review processes including the review and approval of batch documentation and associated documentation.
• Experienced in change control, deviation and CAPA management.
• Experienced in reviewing calibration and qualification documentation.
• Experienced in working with cross-functional teams to identify and implement changes and improvements within pharmaceutical manufacturing and warehousing environments.
• Must have excellent communication, influencing and troubleshooting skills.
• Ability to effectively contribute within a team environment and work on own initiative.
• Meticulous attention to detail.
• Excellent planning and organisational skills.
• Ability to work accurately under pressure and to meet deadlines.
• Familiarity with Trackwise software would be advantageous.

What you will get in return:

• We offer employees not only a competitive salary but also an excellent suite of benefits including: 25 days holiday and your birthday off!
• Company contributory pension package
• Life insurance
• Private Medical Insurance through Vitality
• Internal and external training courses and professional development support
• Free onsite car parking

We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fundraising events.