QC Technical Project Manager

Talentmark 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.

This role 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), the introduction and maintenance of new or existing equipment and technologies, and leading laboratory compliance related activities.

• Ensuring effective management of a team of QC technical specialists ensuring that regular 1:1 meetings take place and that Job Description s, Objectives and performance reviews are up to date and completed on time.
• Ensuring QC Equipment and Electronic Systems are managed effectively to ensure their use in the manufacture, packaging and testing of marketed drug products and provide technical support for the operation, maintenance and improvement of these.
• Creating and maintaining a five year equipment replacement plan to ensure the QC laboratory is equipped with current equipment and software that meet the testing requirements and lead the procurement, validation and qualification of new QC Equipment and Electronic systems.
• Ensuring effective management of New Product Introduction and Method Transfer.
• Ensuring effective management of the education and training of QC team members in the use of specialist equipment and software.
• Approving SOPs and training materials for use and laboratory administration activities for QC Equipment and Electronic systems and approving qualification and validation documentation.
• Leading compliance related activities for the QC team (e.g. global change control, regulatory submissions, ensuring compliance with country specific pharmacopeia's or regulatory requirements) and leading Equipment, Software or Compliance related deviations in accordance with local procedures.

• Educated to degree level or above in a science discipline with significant previous 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 and experience of Method Transfer.
• Experienced as a laboratory administrator and/or end user of QC electronic systems.
• Excellent communication and people management skills to support progression of technically led projects internally and externally.
• Ability to understand and analyse user requirements to facilitate changes and system improvements.
• Good understanding of the requirements of data integrity and application to system management.
• Thorough understanding of GMP Guidelines and Regulations.