Cleaning Validation Specialist

3 months ago

Tredegar, United Kingdom PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To ensure the validated status of all cleaning processes utilised at PCI Tredegar remain in a controlled state in accordance with the required risk based, lifecycle approach.

Main Responsibilities include:

- To partake in Risk Assessments and Change Impact Assessments associated with GxP impacting systems, ensuring a suitable approach to Cleaning Validation is established.
- To ensure the documentation utilised for Cleaning Validation has been generated in compliance with Statutory, Regulatory, Client and Company expectations.
- To work closely with Project Management Teams in Analytical Services, Pharmaceutical Development, Technical Affairs, Operations (inclusive of Engineering), Supply Chain and Clients to ensure projects are progressed in a timely manner.
- To provide support with investigations / discrepancies relating to the cleaning of GxP systems and lead any improvement opportunities identified for cleaning practices, ensuring continuous improve techniques are successfully implemented.
- To support the execution of Cleaning Validation studies, ensuring:

- All activities are completed in a GxP compliant manner.
- Standard Operating Procedures (SOPs) and Work Instructions (WIs) associated with the Validation study are available and adequate for their intended use.
- Training of Key personnel has been conducted and recorded within the training management system.
- All equipment used during a Cleaning Validation study is appropriately qualified and where appropriate calibrated to a recognisable international / national standard.
- Any deviation to the acceptance criteria associated with a Cleaning Validation study is adequately documented and an action plan agreed as required.
- All key findings are adequately reported, concluding whether the Cleaning Validation study has been successful and whether the process is appropriate for routine GxP use.
- To ensure the Site Validation Master Plan is adhered to and maintained in accordance with a risk based, lifecycle approach.
- To be a Subject Matter Expert in Cleaning Validation, and be able to represent PCI at client facing meetings and at audit in this discipline.
- To act in a professional manner at all times when liaising with PCI’s client base, to sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
- To ensure a Continuous Improvement ethos is upheld, periodically reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates and Forms with the purpose of standardising and optimising the Validation approach, whilst still maintaining Regulatory compliance.
- To support with the execution and closure of Validation Studies relating to other Validation disciplines (including; Equipment Qualification, Facility Qualification, Utility Qualification and Computer Systems Validation) when deemed as appropriate by the Validation Manager.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._

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