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Hobson Prior are looking for an CSV Specialist to join a top pharmaceutical organisation who are involved in the manufacture of human blood plasma products. This is a permanent position located in Elstree, Hertfordshire. This is a great opportunity to develop your level of experience and expertise with the aim of developing towards a more senior role.
- Site Subject Matter Expert for Computerised Systems Validation.
- Accountable for developing and managing the site strategy towards CSV.
- Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
- Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
- Support vendors to ensure adherence to, and application of GAMP is aligned with the organisations expectation.
- Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
- Work cross-functionally to ensure site alignment with lifecycle requirements.
- Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
- Support development of CSV competencies within both Validation and across the business.
- Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
- Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
- A willingness to engage in self-directed learning.
- Ability to assimilate new information into their routine working practices.
- A natural tendency towards continuous improvement is required.
- Excellent documentation skills.
- Degree level qualification, science or engineering discipline or equivalent.
- Experienced at leading teams to deliver compliant computerised systems.
- Good understanding of the implementation of the requirements of GAMP 5, adherence with 21CFR Pt11, EU GMP Annex 11.
- Significant experience of validation within a parenteral (bio) pharmaceutical or blood products manufacturing environment (API and/or fill/finish).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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