QC Technical Project Manager

Talentmark; Welwyn; On-site; GBP 60,000 - 90,000; Full time

Job summary

Talentmark is recruiting a QC Technical Project Manager for a global pharmaceutical company based in Hatfield, Hertfordshire. The role leads a team of QC specialists managing laboratory electronic systems (e.g., LIMS), equipment introductions and maintenance, and quality compliance activities.

Key duties include 1:1 staff meetings, ensuring equipment and systems are fit for purpose in manufacturing and testing, and driving qualification, validation, and deviation handling under GMP guidelines.

Qualifications

• Degree in science with significant experience in QC equipment and electronic systems.
• Experience managing QC equipment qualification and validation.
• Experience as a laboratory administrator or user of QC electronic systems.
• Excellent communication and people management skills to progress technically led projects.

Responsibilities

• Manage a team of QC technical specialists and conduct regular 1:1 meetings.
• Oversee QC equipment and electronic systems used in manufacturing, packaging and testing.
• Lead procurement, validation and qualification of QC equipment and electronic systems.
• Drive New Product Introduction and Method Transfer in QC labs.
• Coordinate training and education of QC staff on equipment and software.
• Approve SOPs and training materials for QC equipment and systems.

Skills

People management

Communication skills

Project management

Data analysis

GMP awareness

Needs assessment

Team leadership

Education

Degree in science

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.

It is essential that applicants hold entitlement to work in the UK.