Senior Quality Assurance Officer

2 weeks ago

Corsham, Wiltshire, United Kingdom Qualasept Full time

About us


The Pharmaxo Group is an award winning, market leading pharmaceutical and healthcare business that serves customers, patients and medical professionals across the UK.


We are located in a modern manufacturing and office facility in Corsham Science Park in Wiltshire, just 5 miles from Chippenham and 8 miles from Bath.


The Pharmaxo Group comprises of:

Bath ASU, which produces thousands of aseptically compounded injectable pharmaceutical products each day for hospitals and patients who are fighting cancer, living with chronic disease or in need of pain relief.

Pharmaxo Healthcare, a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.

Pharmaxo Scientific,which develops the innovations in biotechnology, data and information technology that drive our businesses.

Your
role


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

You will manage the day-to-day operations of part of the QA Operations Team.

You will support or deliver tasks related to the Pharmaceutical Quality System, supporting product realisation and ensuringthe PQS remains robust and effective.


Your
duties
&
responsibilities

  • You will manage QA releasing and worksheet checking on the day and late shift. You will 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 selfinspections.
  • You will be responsible for final review of premanufacture 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 nonconformances to the relevant personnel.
  • You will support the training, development and management of other QA team members.
  • You will support and conduct 1:1s and PDRs for QAOs
  • 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 problemsolving 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

Full Job Description can be found here:Senior QA Job Description Feb **
Review
This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company grows.

Benefits

  • Starting salary: £34,000 per annum (up to £37,000 per annum with training validations and KPI's)
  • Annual leave of 25 days + bank holidays (increasing to 27 days after 3 years service)
  • Pension you will be autoenrolled after 3 months of employment at 5% (with an employer contribution of 4%). You can also opt to increase your contribution to 6% to which the employer will contribute 8%.
  • Life assurance 10 x salary with a max of £300,000
  • Access to Employee Assistance Programme, counselling service and virtual GP service

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