QC Technical Project Manager

Talentmark Limited; Hatfield; On-site; GBP 70,000 - 95,000; Full time

Job summary

Talentmark Limited in Hatfield is seeking a QC Technical Project Manager to join a global pharmaceutical company on a permanent basis. You will lead the QC laboratory's technical projects, including equipment, LIMS, and compliance activities.

The role requires a science degree, GMP knowledge, and strong leadership to manage a team of QC specialists and drive validation, method transfer, and continuous improvement in a fast-paced manufacturing environment.

Qualifications

• Degree in a science discipline with significant QC equipment and electronic systems management experience.
• GMP knowledge and regulatory requirements in pharmaceutical QC.
• Experience with method transfer and equipment qualification/validation.
• Strong communication and people management skills to drive project delivery.

Responsibilities

• Lead a team of QC technical specialists with regular 1:1 meetings and performance reviews.
• Ensure QC equipment and electronic systems used in manufacture, packaging and testing are properly managed.
• Create and maintain a five-year equipment replacement plan and oversee procurement, validation and qualification.
• Manage New Product Introduction and Method Transfer.
• Oversee education and training of QC staff in equipment and software use.
• Approve SOPs, training materials and qualification/validation documentation.
• Lead compliance activities (change control, regulatory submissions, deviations) for QC.

Skills

Communication

People management

Requirements analysis

Education

Science degree or higher

Tools

LIMS

Validation processes

Job description

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.

Role

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 Descriptions, 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.

Your Background

• 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.