QC Technical Project Manager

Talentmark; Hatfield; On-site; GBP 65,000 - 90,000; Full time

Job summary

Talentmark are recruiting for a QC Technical Project Manager to join a global pharmaceutical company based in Hatfield, Hertfordshire, on a permanent basis. You will manage the QC laboratory's technical projects, lead a team of specialists, and oversee electronic systems like LIMS, equipment upgrades, and compliance activities.

The role requires a degree in science with extensive experience in QC equipment management, method transfer, GMP, and data integrity.

Qualifications

• Educated to degree level in a science discipline with experience in technical management of QC equipment and electronic systems.
• Strong knowledge of pharmaceutical QC equipment, electronic systems, qualification/validation, and method transfer.
• Experience as a laboratory administrator or end user of QC electronic systems.
• Excellent communication and people management skills to drive technical projects.
• Understanding data integrity requirements for system management.
• Solid grasp of GMP guidelines and regulatory expectations.

Responsibilities

• Manage a team of QC technical specialists with regular 1:1s and up-to-date objectives and reviews.
• Oversee QC equipment and electronic systems used in manufacture, packaging and testing of products.
• Create and maintain a five-year equipment replacement plan and lead procurement/validation.
• Lead New Product Introduction and Method Transfer activities.
• Coordinate education and training on equipment and software for QC staff.
• Approve SOPs, training materials, and qualification/validation documentation.
• Lead global change control, regulatory submissions, and compliance-related deviations.

Skills

People management

QC Equipment

Electronic systems

Method transfer

GMP compliance

Data integrity

Regulatory knowledge

Education

Science degree

Tools

LIMS

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.

Key duties will include:

• 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.