Quality Assurance Lead

**Quality Assurance Lead - Full Time & Part Time**

**About us**

The Qualasept Pharmaxo Holdings Limited (QPHL) Group operates within the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors.

Qualasept Ltd t/a Bath ASU produces over 3,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need of pain relief. Through our scientificand technology capabilities, the team continuously develops new and innovative methods to improve our products and services.

Pharmaxo Pharmacy Services Limited is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.

Microgenetics Ltd is a bio-technology business, currently offering two products: SmartControl and SwiftDetect. It operates both in the pharmaceutical and agricultural markets, bringing innovative microbiological testing and monitoring services, methodologiesand technologies.

Corsham Science Ltd uses cutting-edge science and technology to deliver healthcare services, medicines, and microbiological testing products.

The QPHL Group now includes over 400 people with a leading-edge turnover greater than £260 million.

We have invested in a new, multi-million pound manufacturing facility and offices in Corsham, Wiltshire

**The 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.

**You will be responsible for**:
Assisting the Quality Assurance Manager with 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.

**What you will be doing**:

- 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
- Be part of the Bath ASU on-call rota as required

**Experience and Skills, you will need**:

- You will have previous experience in a QA role, experience in a Sterility role would be an advantage
- 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

**Qualities you will need**:

- The ability to influence others at all levels of the business and lead change
- A problem solver
- Ability to work under pressure within a fast and ever-changing environment
- The ability to empathise - both with our patients and the group
- Diligent approach

**In return we can offer**:

- Salary £32,106 - £39,627 per annum (dependent on experience, skills, knowledge and performance)
- 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

**_“Do you want to work for an organisation that makes life-changing pharmaceuticals?_