Validation Lead

**Validation Lead**

**Your role**

As Validation Lead 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 provide advice on all aspects of Validation to support the quality, efficacy andsafety 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 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, Supplier Assurance.

Lead the following with respect to the above:

- Quality Metrics, Audit & Inspection, New product Introduction, Quality Risk Management, CAPA, Recall, Regulatory Updates, Complaints, Deviations, Change Control, Trends, Environmental Monitoring, Stability, Documentation.
- 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. Write or advise on the writing of validation/qualification final reports that present, summarise and offer conclusions on the validity of the processesbased on objective evidence, obtain necessary approvals.
- 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

**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