Senior QA Officer - Projects
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 development and 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.
The Role:
The Senior QA Officer will be the QA representative on both new and existing project teams. They will be responsible for managing all project related quality actions, helping and advising the project team in quality related matters and liaising with clients and customers to ensure their quality expectations are met.
As a key part of the project team the role will work closely with project managers, clinical and commercial manufacturing teams and Quality Control teams .
Main duties and responsibilities:
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, CAPAs 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.
Document author for Quality related documents
Responsibility for leading quality related investigations related to project related deviations and CAPAs
General role responsibilities
Understand & follow the companys Health & Safety Policy & Procedures & report all accidents or any unsafe conditions in the workplace
Ensure training has been received before undertaking specific duties & that all training is recorded in training records
Adhere to all HR policies & procedures, specifically including all absence policies and procedures
Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular & timely basis
Essential skills required:
Experience working in Quality Assurance on a pharmaceutical manufacturing site.
Very good communication skills and experience of demonstratable experience of working as part of cross functional teams.
Experienced in change control, deviation and CAPA management.
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.
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
Upperton Rewards discount platform through reward gateway
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 fund raising events.
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