Senior Validation Specialist
Are you an experienced Validation specialist looking for a great career move? A major biopharma manufacturer in the Midlands would like to speak with you about an exciting role with full autonomy across an expending site.
Why you should take an interest in this role: Excellent salary and benefits to start with as well as positive company culture, a site that is expanding and a diverse and talented team already in place.
Role & Responsibilities
- Support continuous validation and compliance for site master plan including cGMP, facilities, equipment, utilities, laboratory methods, processes and computerised systems.
- Lead validation projects for site activities as well as revising current processes to include the manufacturing process, plant systems and cleaning equipment.
- Work closely with QC/QA, Production and Engineering departments to identify projects and problems requiring validation support.
- Provide QA/compliance support to Cross-functional teams to ensure that activities associated with facility qualification and transfer of new products comply with regulatory requirements.
- Review and approve transfer protocols, summary reports, strategy documents, qualification documentation, change control-related documentation, masterbatch records etc.to support new product introduction.
- Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories, Engineering and outside contractors providing leadership, training and guidance as required.
- Develop new and review existing monitoring and control systems for process performance, product quality etc to provide continued and suitability and capability of processes.
- Drive continuous improvement qualification and validation initiatives which impact cycle time, productivity, efficiency and quality utilising lean methodology.
Qualifications and Education Requirements:
- Level 8 Degree in relevant discipline.
- Evidence of developing, implementing and maintaining Quality Systems and Standards at the manufacturing site level by ICHQ10
- Demonstrated knowledge and success validating of Quality Systems
- Minimum of 3 years’ experience working within the Pharma industry in a similar role essential.
- Excellent communications skills and proven ability to liaise well with other departments.
- Continuous improvement and innovative mindset.
Apply for this job now or get in touch with Michéal on 0906490485
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