Validation Manager

**Validation Manager**

**About us**

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 scientific and technologycapabilities, the team continuously develops new and innovative methods to improve our products and services.

Pharmaxo Pharmacy Services Ltd 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**

As Validation Manager you will deliver a safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business. The role holder will be expected to advise on all aspects of Validation to support the quality, efficacy and safetyof 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 reviewof 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 leading the trending and review of validation data; for coordinating and producing investigation reports and assessing CAPA action items.

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

**Your duties & responsibilities**

As part of the Quality Team, you will be accountable for the following Key Quality process:

- Validation (Equipment / Facilities validation, Computer System validation as well as Process / Product validation), Data Integrity Assessments.
- Lead the following with respect to the above:
Quality Metrics, Audit & Inspection, Quality Risk Management, CAPA, Regulatory Updates, Deviations, Change Control, Trends, Environmental Monitoring, Documentation.
- Line management of the Validation Lead, including assessing and implementing training and development requirements.
- Maintain a Master Validation Plan, review and implement all necessary standard operating procedures for Bath ASU processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation ofcritical systems and utilities in line with GMP requirements / company policies and procedures.
- Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes within agreed timescales.
- Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
- Draft URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system
- Develop and prepare protocols for process and cleaning validation, equipment commissioning and qualification.
- Ensure the qualification/validation of the facility, equipment and processes comply with current international, regulatory and / or ISO requirements.
- Review and analyse analytical and physical data generated from executed validation/qualification activities.
- Work with Bath ASU personnel to generate risk management deliverables for new projects and continuous improvement activities (such as Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, FailureMode and Effects Analysis).
- Support qualification and validation training activities.
- Oversee work of those undertaking validation activities.
- Participate in Management Review Meetings Provide and provide status and progress reports for validation/qualification activities or projects ensuring timely and effective communication and escalation where required.
- Communicate and liaise with the various internal departments and external customers involved in the qualification and validation work to ensure the efficient performance of the related tasks
- Act as the QA lead presenting qualification activities to an auditor
- Undertake any additional tasks and projects as required by the Head of Quality

**Secondary duties**
- Participate in the on-call rota
- Undertake and record continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
- Support the development of activities and policies aimed at improving the effectiveness and efficiency of the service and improvement of the quality management system.
- To support the training and development of Production and QA staff.
- Other duties as required by the Head of Quality

**The skills & attributes you will bring**
- Dynamic, self-motivated, proactive approach to taking on challenging assignment
- Creative and analytical thinking
- Excellent planning capability and be able to envision short term milestones which the company must achieve to succeed in the long term

**Benefits**

In return we offer rewards and benefits including:

- 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