Pharmaceutical Technical Director
2 weeks ago
CK Group is a leading pharmaceutical company seeking a highly skilled Pharmaceutical Technical Director to join their team in Hatfield, Hertfordshire, on a permanent basis.
About the RoleThis is a unique opportunity to lead technical projects within the QC laboratory, managing a team of technical specialists and ensuring the effective operation and maintenance of laboratory electronic systems, equipment, and technologies.
Key Responsibilities:- Lead a team of QC Technical Specialists, providing guidance and support to ensure regular 1:1 meetings, up-to-date job descriptions, objectives, and performance reviews.
- Develop and implement resource plans to meet team requirements, monitoring capacity through appropriate planning.
- Provide technical support for the operation, maintenance, and improvement of QC Equipment and Electronic systems to support business needs.
- Lead the procurement, validation, and qualification of new QC Equipment and Electronic systems, deploying new/upgraded systems internally.
- Approve qualification and validation documentation in line with procedures.
- Collaborate with the IT Team to ensure all QC Equipment and Electronic Systems are deployed and maintained in line with IT policies.
- Lead troubleshooting and resolution of user and technical equipment/system issues, promoting best practices and escalating issues to the Head of QC.
- 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, including global change control, regulatory submissions, and ensuring compliance with country-specific pharmacopeia or regulatory requirements.
- Identify and implement continuous improvement opportunities resulting in more efficient and compliant ways of working.
To succeed in this role, you should have:
- 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.
- A thorough understanding of GMP Guidelines and Regulations.
- Maintain knowledge and understanding of technical advancements in QC Equipment and Electronic systems.
Estimated salary: £70,000 - £85,000 per annum, depending on experience.
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