Senior Quality Assurance Officer

**Senior Quality Assurance Officer**

**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

**Your role**

You will be responsible for the delivery of safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business.

You will be managing the day to day operations of the shift pattern they have been assigned too regarding the QA Operations Team, and you will support or deliver any tasks related to the Pharmaceutical Quality System in support of product realisation orto ensure the PQS remains robust and effective.

**Your duties & responsibilities**
- You will manage the QA releasing and worksheet checking on the day and late shift. Ensure that the shift is working efficiently and reassign people according to workflow.
- You will continue to provide support in the rota system that operates within the QA Team to deliver our service commitments. This includes Worksheet Checking, Batch Release, Batch documentation review, and Assay review.
- You will produce and interpret regular reports against predetermined KPIs for the QA team, for dissemination to the QA Operations Team Leader(s) or the wider Quality Team
- You will ensure the timely investigation of complaints, deviations, and quality exceptions from the quality system, and approve initial investigations, assign appropriate corrective actions, and recommend preventative measures.
- You will support and deliver against objectives set out through the PQS system or Bath ASU improvements or projects..
- You will participate in quality audits and self-inspections.
- You will be responsible for final review of pre-manufacture batch documentation, following GMP guidelines.
- You will be responsible for the Approval for Use (final release) of all products manufactured or
repackaged according to licensing requirements, GMP and professional discretion.
- You will act as a primary point of contact as part of the QA team providing information to other departments dealing with the production processes.
- You will undertake continuing professional development and attend any suitable training and
update courses as deemed necessary and ensure a high level of competency is achieved.
- You will highlight any non-conformances to the relevant personnel.
- You will support the training and development of other QA team members.
- You will Deputise for the QA Operations Leader during holidays and absence.

**The skills & attributes you will bring**
- You will have knowledge and understanding of GMP
- You will have good problem-solving skills
- You will have excellent language, written and numerical Skills
- You will have good communication and interpersonal skills
- You will have the ability to plan and prioritise workload
- You will have great attention to detail

**Working hours**

37.5 hours including evenings and weekends on a rota basis.

**In return we can offer**:

- Salary: £29,100 - £34,600
- 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?_