Cleaning Validation Specialist (Pharma)
- Reference: JLS CV
- Location: Merthyr Tydfil
- Salary: £40000-£50000
- Type: Full time
- Start: ASAP
Just Life Sciences, are the, specialist Life Sciences Recruitment Consultancy based in Cardiff, and are seeking a Cleaning Validation Specialist.
You will ensure the delivery of a fully compliant cleaning validation and verification on processes for the site, whilst adhering to GMP and regulatory requirements.
The role demands undoubted technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.
Qualifications, Skills and Experience
- Technical/Quality Assurance
- ·All cleaning validation related activities, including: -
- Management of related validation master plans.
- Preparation, execution and review of validation documentation in relation to equipment and facility cleaning.
- Review of third party generated protocols and reports where necessary.
- Management of deviations related to cleaning validation.
- Oversight of any exceptions / deviations in relation to cleaning verification.
- To comply with internal external Health & Safety and Environmental Standards as required.
- Use of Quality Risk Management systems to ensure that risks are adequately controlled in accordance with current requirements.
- Client-driven cleaning validation activities – this will involve direct communication with the Client.
- Ensure appropriate investigations of deviations, errors, complaints, failures and adverse events requiring documented review and action.
- To review non-compliance identified by audit, deviations and complaints and use technical/professional judgement to make appropriate product quality decisions (in association with site QPs) and initiate and promote quality improvements.
- To actively pursue continued improvement in the services provided, targets achieved and business needs.
- To provide key performance indicators for review by the Head of QMS, and initiate corrective and preventative actions based on this data.
- To undertake reasonable tasks or projects as and when required within the scope of the job holder’s capabilities and responsibilities.
- A relevant scientific or engineering degree is essential. Qualified Person status or working towards QP status would be an advantage.
- GMP LEVEL 1
- You will have experience in a similar role in the pharmaceutical industry with up to date credentials relevant to both investigational (clinical trial) and marketed (commercial products).
- Familiarity with ISPE cleaning and cross-contamination guidance.
- Excellent interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
- Proven ability and desire to continuously improve, by seeking new approaches, generating ideas & demonstrating a determination to secure business advantage from such initiatives.
- Proven ability to plan effectively, by taking a long-term view and developing structured action plans to meet business objectives.
- If you have the relevant experience and are seeking a new challenge within the Life Sciences Sector then please email your details to justyn withey at justlifesciences dot com
Just Life Sciences
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