Marketing & Business Development Specialist Glasgow PermanentDo you have a background in science with experience working in a commercial or marketing role?Are you an experienced...
Validation Manager - Glasgow - PermanentCan you perform well in a fast paced environment? Can you work well in a team and also independently on your own initiative?Do you appreciate strong Company values? Then you will fit in well with our client Sartorius Stedim BioOutsource Ltd.On behalf of our client SRG are currently recruiting for a Validation Manager. The Validation Manager is accountable for ensuring that all validation programmes across Sartorius Stedim BioOutsource's sites meet regulatory expectations and are fit for purposes for services our client provides.In return our client can offer you a competitive salary, a generous benefits package, full on the job training, and significant opportunity for personal growth and development within a rapidly expanding successful CRO.What you can look forward to achieving
- In collaboration with the Head of Operational Support and members of the Operations Support Leadership Team, develop functional goals and drive and monitor performance against site goals, objectives and KPIs;- Accountable for the implementation and delivery of validation master plans - facility, equipment, process, people;- Manage the Validation Maintenance program, inclusive of validation plans, schedules and driving operational improvements into the manufacturing site;- Manage activities of approved contractor validation engineers and work with site-based teams to ensure the validation maintenance program requirements are met for all operational sites- Maintain systems to monitor and track team metrics - Representing the validation team on cross-site and enterprise projects - Providing oversight of the validation labs and equipment to maintain the validation program- Representing the validation function to Commercial CMC teams - Providing technical support for product / process transfers into and out of the biologics manufacturing site- Providing validation assessments to determine scope of validation needed for automation, equipment, facility, utility changes for internal manufacturing operations - Supporting inspection and inspection readiness activities
- Strong focus on customer service, attention to detail, and continuous improvement activities to provide impeccable service to clients.
- Represent Validation team on project teams
- Prepare team for regulatory inspections and manage inspection responsibilities for the validation team.
- Develop organisational capabilities to ensure continued staff development.
- Promote and maintain a safe work environment.
Skills and experience that you need to bring to the Company
- Degree in relevant scientific or engineering field
- Proven track record in validation provision preferably from biologics manufacturing within a GMP environment
- Excellent knowledge of EU and FDA Validation regulations
- Track record of validation SME in client and regulatory audits
- Proven track record in developing validation strategy - e.g. defining equipment IOPQ plans and schedules
- Experience in successful management of complex validation projects
- In depth knowledge of the regulations and guidelines for validation - Guidance for Industry Process Validation: General Principles and Practices, ICHQ8r2, ICHQ10, ICHQ9, EMA/CHMP/CVMP/QWP/70278/2012-Rev1, EU Vol 4 Annex 15
- Understanding of process validation - subject matter expert guidance.
- Proven people manager and leader capable of developing people and teams
- Operational Excellence experience to ensure value added and effective operations
- Experience of cell culture or microbiology scientific background would be an advantage.
Other Job Requirements
- Routine local travel between sites is expected. Periodic travel may be required for business meetings with corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities. Incumbent will be required to carry an iPhone and be on call as required to support operations.
Please apply online or contact Pamela for further information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.