Validation​/Quality Assurance Specialist, Pharmaceutical

Position: Validation/ Quality Assurance Specialist, Pharmaceutical
Validation/ Quality Assurance Specialist, Pharmaceutical

Location:

Derby
Salary: £30,000-£34,000 depending on experience (plus company bonus)

Hours:

Monday - Friday, days, 35h per week

Russell Taylor is working with a leading pharmaceutical manufacturer (CMO) who are continuing to grow; 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 will play a key role in supporting site validation activities across a range of projects. This is a great opportunity for someone with GMP validation experience looking to build on their existing knowledge within a supportive and expanding team. Candidates with equipment or process validation experience from pharmaceutical or other GMP-regulated manufacturing environments are encouraged to apply.

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:

➢ Cleaning validation
➢ Computerised systems validation
➢ Equipment and utilities qualification
➢ Process 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 validation documentation where required.

• Contribute to knowledge sharing and support colleagues across the validation team.

The Person :

• Will hold a degree (or equivalent) in a STEM-related subject, or have relevant hands-on validation experience within a GMP-regulated manufacturing environment.

• Experience in validation within a cGMP setting, ideally involving process validation, equipment qualification and/or utilities validation. Candidates with exposure to validation activities in pharmaceutical, medical device, or other GMP manufacturing settings are welcome.

• To be clear, this role is focused on manufacturing/site validation rather than analytical method validation within QC.

• Experience working in a quality or regulated environment (cGMP / MHRA / GMP).

• Comfortable reviewing data and using IT systems to document and communicate results effectively.

• Strong interpersonal skills with the ability to work collaboratively across teams; fluent in English (written and verbal).

• Keen to develop validation knowledge further and contribute within a growing team environment.

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