Quality Control Team Leader

Job Description

About UsBath ASU produces over 3,000 aseptically compounded injectable pharmaceutical products each day to hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need pain relief. Through our scientific and technology capabilities,the team continuously develops new and innovative methods to improve our products and services.Bath ASU is part of the QPHL Group which operates in the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors. Formed in 2000 at the University of Bath the company relocated in 2006 to its current home in Corsham. The companyhas continued to grow in both capability and capacity.Your role:The QC team are responsible for ensuring the delivery of a safe, quality aseptic manufacturing service to meet cGMP requirements and the needs of the business. The role holder will be expected to provide advice on all aspects of sterility assurance to supportthe quality, efficacy and safety of all products manufactured at Bath ASU.The QC team are the primary point of contact for all aspects of contamination control / sterility assurance, providing advice to Bath ASU personnel to ensure there is QC oversight across all operations and escalate issues to the Quality Assurance Manageror Head of Quality when required.To assist the Quality Assurance Manager with the daily operation and development of thePharmaceutical Quality System (PQS), contributing to the Quality oversight of all operations atBath ASU and the effectiveness and efficiency of the QC Team.You will be managing the day to day operation of the Quality Control department and the development of the members of the QC team. You will support or deliver tasks assigned to the QC Team or in support of product testing and realization, validation andcalibration activities on site.The role holder will also take responsibility for key quality processes within the PQS and the approval of documentation. The role holder may also lead Quality Improvement Projects.Your Duties & responsibilities

• Maintain an overview of all aspects of Quality Control at Bath ASU to ensure its suitability and effectiveness and ensure non-compliance issues are addressed.
• As QC Operations Team Leader, you will be accountable for the key Pharmaceutical Quality System processes within QC.
• Manage the QC team daily operational requirements including rotas, holiday, sickness & absence, recruitment, induction and training.
• Ensure supervision of the QC team to ensure all tasks and responsibilities are achieved in line with SOPs, in a timely manner and to an appropriate standard.
• Apply and share technical knowledge of simple instrumental, analytical methods including UV spectrophotometry and flame photometry to product assays.
• Arrange regular meetings with the QC team to review actions, set targets and provide support.
• Ensure staff working in the Quality Control Laboratory do so in a safe and effective manner and in accordance with the recommendations of the Guide to Good Laboratory Practice, local procedures and all relevant safety regulations.
• Liaise with Production Management to schedule environmental monitoring of Production areas.
• Liaise with Production Management and Maintenance department to schedule and support calibration and validation activities on time.
• Ensure stocks of materials and consumables are maintained at required levels.
• Ensure all QC facilities and equipment are kept clean and tidy.
• Ensure SOPs are complied with and processes and procedures are reviewed and kept up to date.
• Generation, coordination and GMP approval of key documentation within the PQS.
• Identify the requirement for and implement training and development of QC team members.
• Maintain and approve the training records for the QC team members and ensure they are complete and kept up to date.
• Perform Personal development Reviews (PDR), performance management, objective-setting, and development of action plans.
• Produce, interpret and publish regular status reports on relevant PQS processes for Bath ASU Management
• Ensure consistent communication directly with the Production Management team to ensure priorities and resources are aligned to deliver the PQS requirements and the Production Plan
• Escalate issues to directly to key departments in a timely manner, ensuring Senior Management Team are informed.
• Conduct internal and external audits per the defined audit schedules.
• Support periodic Regulatory GMP/ GDP Inspections through staff and site preparation.
• Lead and assist internal and client audits
• Lead or support gap analysis, risk assessments and risk management
• Lead and support investigations and root cause analyses. Identify effective CAPA
• Maintain quality regulation and guideline knowledge, participating in the assessment of any business implications of changes.
• Identify, author and deliver training on GxP topics and Pharmaceutical Quality System processes.
• Undertake continuing professional development and attend any suitable training and update courses as required and ensure a high level of competence is achieved.

The skills & attributes you will bring

• You will have previous experience in a Quality Leadership role. Experience in a Sterility role would be an advantage
• You will have led Quality-related Improvement Activities
• You will have proven problem-solving skills
• You will have confident risk management skills
• You will have excellent attention to detail

In return we offer rewards and benefits including:

• 29 days holiday inclusive of bank holiday (Increasing with service)
• Generous Pension scheme
• Life Assurance
• Quarterly Company bonus scheme
• Additional non-contractual benefits including free breakfast and outdoor gym

Closing date: Sat 8th January 2022By clicking apply you will be taken to our careers page to complete your application.