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Senior Quality Assurance Lead

4 months ago

Corsham, United Kingdom Bath ASU Full time

**Senior Quality Assurance Lead**

**About us**

Bath ASU is the largest privately-owned pharmaceutical company in the UK and with our sister companies Pharmaxo, Microgenetics and Corsham Science Ltd we employ over 400 team members; the best part is that number is ever-growing. We are an aseptic specialsmanufacturer based in Corsham, Wiltshire. Formed in 2006 from Bath University, we are a growing company and supply life-changing medicines to over 275 hospitals UK-wide.

**Your role**

As an integral member of the QA team, enable the delivery 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 cGMP to support the quality,efficacy and safety of all products manufactured at Bath ASU.

To manage the daily operation and development of the Pharmaceutical Quality System (PQS), contributing to the Quality oversight of all operations at Bath ASU and the effectiveness and efficiency of the Quality Team.

**Your duties & responsibilities**
- Manage the QA lead team with regards to the daily requirements including rotas, holiday, sickness & absence, recruitment, training and induction to ensure the team are adequately skilled and resourced.
- Identify the requirement for, and implement training and development of QA Lead team members.
- Maintain and approve the training records for all QA Lead team members and ensure they are complete and kept up to date.
- Perform appraisals, assessing performance, objective setting, and developing action plans for the QA Lead team
- Maintain an overview of all aspects of the PQS to ensure its suitability and effectiveness and ensure non-compliance issues are addressed.
- As part of the Quality Assurance Team you will be accountable for up to 5 Key Quality Process such as:
CAPA, Recall, Regulatory Updates, Complaints, Deviations, Change Control, Trends, Environmental Monitoring, Supplier Assurance, Stability, Documentation, Quality Metrics, Audit & Inspection, Quality Risk Management, Data Integrity and Validation.
- Produce regular reports detailing the status of the PQS for dissemination to the Head of Quality, QA Manager, Production Management, Managing Director and Audit/Risk Committee.
- Escalation of issues to the Head of Quality / QA Manager.
- Generation and GMP approval of key documentation within the PQS.
- Conduct internal audits of the PQS as per the defined audit schedule.
- Assist with periodic Regulatory GMP/ GDP Inspections and site preparation.
- Lead and assist internal audits and inspections by clients.
- Lead or take part in gap analysis, risk assessments and risk management.
- Drive the timely implementation of risk-based changes and manage quality led improvement projects.
- Lead investigations to determine root cause and identify effective CAPA
- Ensure that SOPs are complied with and processes and procedures kept current.
- Maintain awareness of changes to quality regulations and guidelines, participating in the assessment of any business implications of these changes.
- Identify and deliver training on GxP topics and Quality Management System processes.
- Participate in the out of hours rota system for monitoring the environmental status of the building and its equipment.
- Undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
- Ensure compliance with COSHH and Health and Safety regulations and departmental SOP’s.
- Be part of the Bath ASU on-call rota as required

**Secondary duties (or those that may be required to support the Quality Assurance Team)**:

- To be responsible for the Approval for Use (release) of all products manufactured or repackaged within Qualasept according to licensing requirements, GMP and professional discretion.
- Participate in any rota system that may operate within the QA team in order to deliver our service commitments.
- To support the training and development of Production and QA staff.
- Other duties as required by the QA Manager.

**The skills & attributes you will bring**
- You will have previous experience in a QA role, experience in a Sterility role would be an advantage
- You will have supervisory or management experience
- You will have led QA related Improvement Activities
- You will have proven problem-solving skills
- You will have confident risk management
- You will have excellent attention to detail

**Benefits**

In return we offer rewards and benefits including:

- Competitive salary
- 29 days holiday, inclusive of bank holidays. Increasing with service
- Generous Pension scheme
- Life Assurance
- Company bonus scheme
- Additional non-contractual benefits including free breakfast and outdoor gym