Validation Officer

4 months ago

Corsham, 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 (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 at Bath ASU**

As Validation Officer you will deliver 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.

**Your duties & responsibilities**
- As part of the Validation Team, you will be accountable for the following Key Quality processes:

- Validation (Equipment / Facilities validation, Computer System validation as well as Process / Product validation), Data Integrity Assessments.
- Participate in the following:

- Quality Metrics, Audit & Inspection, Quality Risk Management, CAPA, Regulatory Updates, Deviations, Change Control, Trending, Environmental Monitoring, Documentation, Facility & Equipment PPM Review.
- Support the implementation of all necessary standard operating procedures for Bath ASU processes, equipment installation and support operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation activities of critical systems and utilities in line with GMP requirements / company policies and procedures.
- Review, plan, schedule and implement requalification activities including facility systems, manufacturing equipment and processes, analytical instrumentation, temperature mapping within agreed timescales.
- Recommend validation and qualification approaches, strategies, priorities and required resources during validation/requalification activities.
- Manage, lead & supervise a cross-departmental team involving validation/requalification activities.
- Develop and prepare protocols for the qualification and requalification of equipment, computer systems and cGMP processes.
- Ensure the qualification/validation of the facility, equipment and processes comply with current international, regulatory and / or ISO requirements.
- Ensure that scheduled work orders and PPM schedules are maintained.
- 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 processes based on objective evidence, obtain necessary approvals.
- Support qualification and validation training activities.
- Oversee work of those undertaking validation/requalification activities.
- Participate in Validation/Maintenance Review Meetings 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.
- Be involved in the presentation of validation/qualification activities to an auditor.
- To support and lead, members of the Validation team.
- Undertake any additional tasks a

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