Location: Derby
Salary: £30,000- £34,000 depending on experience (company bonus too)
Hours: Monday - Fridays days 35h per week
Russell Taylor is working exclusively with a leading pharmaceutical manufacturer (CMO) who are very much growing; backed by significant investment, new leadership, and modernised validation systems and processes, the company is expanding its validation team at this time. The Validation Specialist (level 3) will play a vital role in the development of validation team too.
The role:
Plan and execute validation activities in line with site validation plans and project timelines.
• Author and maintain validation protocols and reports across multiple validation areas such as:
ØCleaning validation
ØComputerised systems validation
ØEquipment and utilities qualification
ØProcess validation
• Interpret validation data against predefined acceptance criteria and document outcomes appropriately.
• Execute validation activities while minimising disruption to manufacturing operations.
• Collaborate with cross-functional teams to deliver validation programmes and report outcomes.
• Maintain validated status of systems, processes, equipment, utilities and cleaning procedures.
• Support and participate in site validation projects and cross-functional teams.
• Generate and execute protocols and reports for non-routine quality or validation-related projects.
• Review analytical data generated by the QC laboratory as part of validation activities.
• Maintain and report validation-related KPIs to support quality performance monitoring.
• Support regulatory inspections and internal audits, including completion of corrective actions where required.
• Investigate non-conformances, performing root cause analysis and risk assessment.
• Support the ongoing maintenance of the Site Validation Master Plan (VMP).
• Ensure validation procedures, SOPs and work instructions, remain compliant and up to date.
• Review and approve validation documentation where required.
• Provide guidance and training to junior validation team members.
The Person:
• Will hold a degree (or equivalent) in a STEM related subject, or have sufficient experience validation experience (process and equipment) in a GMP- setting
• Substantial validation experience (process and/or equipment) in a cGMP setting, to be clear we aren't looking for method validation experience for this role in QC settings.
• Experience working in a quality environment (cGMP/ MHRA)
• Experience working with data review and using IT systems to communicate results effectively.
• Strong interpersonal skills needed, fluent in English (written and verbal)
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us
Salary description
£32000.00 - £34000.00 per year