Senior QA Officer

Location:

Nottingham, UK

Type:

Full time, permanent

Senior QA Officer

Overview:

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.

Role Title:  Senior QA Officer

Reporting to:  QA Manager

Hours of Work:  37.5 hours per week Monday to Friday. Core hours are 8am to 4pm. However, you may be required to work flexible around these core hours as necessary to meet the demands of the business.

The Role:

Working as a Senior Quality Assurance Officer, primarily within a small team in the GMP Quality department. The role will be varied, using various tools to address and coach Change Control, Deviations, OOS and CAPA.

The use and experience of Data Integrity, Auditing/Self Inspections, Document Control, Supplier Approval, Qualification and Risk Assessments, analysing and trending of data will be used frequently therefore experience is essential.

Main Duties and Responsibilities: 

  • Being the lead QA representative supporting project meetings which will include customer facing activities where required
  • Advise 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
  • Performing Self inspections

Essential Skills and Experience:

  • Experience working in Quality Assurance on a pharmaceutical manufacturing site with demonstratable leadership responsibilities
  • Very Good Communication skills and experience of demonstratable experience of working as part of cross functional teams
  • 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

What You Will Get in Return:

We offer employees not only a competitive salary but also an excellent suite of benefits including:

  • 25 days plus bank holidays and your birthday off!
  • Annual bonus based on company and individual performance
  • 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.

Applicants must have the required Right to Work in the UK documentation

Closing date for applications is 21st May 2024

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