QC Technical Project Manager

CK Group are recruiting for a QC Technical Project Manager, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

This job is responsible for the management of all technical projects within the QC laboratory. This includes leading a team of technical specialists, that will manage laboratory electronic systems (e.g. LIMS and CDS), the introduction and maintenance of new or existing equipment and technologies, and leading laboratory compliance related activities

Key duties will include :

• Management of a team of QC Technical Specialists, ensuring that regular 1:1 meetings take place and that Job Descriptions, Objectives and performance reviews are up to date and completed on time.
• Ensuring resource requirements for the team are understood and monitored through appropriate capacity planning.
• Provide technical support for the operation, maintenance and improvement of QC Equipment and Electronic systems to support the business needs.
• Lead the procurement, validation and qualification of new QC Equipment and Electronic systems, ensuring appropriate project management is in place and deploy new/upgraded QC Equipment and Electronic systems internally.
• Approve qualification and validation documentation in line with procedures.
• Collaborate with the IT Team ensuring all QC Equipment and Electronic Systems are deployed and maintained in line with IT policies.
• Lead the troubleshooting and resolution of user and technical equipment/system issues, promote best practices and escalate issues to the Head of QC in a timely manner.
• Lead Equipment, Software or Compliance related deviations in accordance with local procedures.
• Approve SOPs and training materials for use and laboratory administration activities for QC Equipment and Electronic systems.
• Lead/Sponsor change control processes to ensure changes are managed in line with procedures and the requirements for qualification and validation are included.
• Lead compliance related activities for the QC team (e.g. global change control, regulatory submissions, ensuring compliance with country specific pharmacopeia’s or regulatory requirements).
• Identify and implement continuous improvement opportunities that result in more efficient and compliant ways of working.   
• To support internal and external audits processes and audit schedules as appropriate and support the preparation and hosting of competent authority inspections.

Your Background:

• Educated to degree level or above in a Scientific discipline.
• Significant experience in the technical management of QC Equipment and Electronic Systems.
• Strong working knowledge of pharmaceutical Quality Control Equipment and Electronic systems, including their qualification and validation.
• Experienced as a laboratory administrator and/or end user of QC electronic systems.
• Excellent communication and good people management skills to support progression of technically led projects internally and externally.
• Thorough understanding of GMP Guidelines and Regulations.
• Maintain knowledge and understanding of technical advancements in QC Equipment and Electronic systems.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 109 117 in all correspondence.