Validation Lead in Corsham

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 (sterile) 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 which is 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 as Validation Lead will involve delivering quality assurance services to meet cGMP requirements and the needs of the business. The role holder will be expected to provide advice on all aspects of Validation to support the quality, efficacy and safety of all products manufactured at Bath ASU.

You will be involved in the complete life cycle for commissioning of facilities, equipment, utilities, and processes, with focus on end-to-end Validation. This includes following the entire Validation Life Cycle, from the generation, execution, and review of life cycle validations documentation, developing some Key Validation Deliverables, through to assessing and mitigating Risks, planning for Validation approach and Test Strategy, Analysis, Review & Approval of Requirements and Change Management.

This position will support the Pharmaceutical Quality Management System through the creation of appropriate validation/qualification reports and presentations. You are responsible for the generation, trending, and review of validation data; for coordinating and producing validation documentation, reports and assessing compliance requirements for equipment, computer systems and cGMP processes.

The role will involve liaising with departments including QA / QC, Production, Warehouse, IT and Maintenance as well as visits to the aseptic processing facilities.

We want everyone to have an equal opportunity to apply for this role. If you require any adjustments, or would prefer to apply in an alternative format, please contact careers@pharmaxo.com and we will be happy to support you through the process.

Benefits:

• Annual leave of 25 days + bank holidays (increasing to 27 days after 3 years’ service)
• Pension - you will be auto-enrolled 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%.
• Generous Life Assurance package
• Access to Employee Assistance Programme, counselling service and virtual GP service
• Pharmaxo Engage is our Reward & Recognition intranet which includes shopping discounts and benefits.

Experience:

At least 2 years working within a validation role under GMP.