QC Senior Equipment Technical Specialist
Talentmark are recruiting for a QC Senior Equipment Technical Specialist, to join a long-established global pharma company, based in Hatfield on a 12-month temporary basis.
The Role:
The Senior Technical Specialist will be responsible for supporting all QC equipment and electronic systems through the equipment’s life cycle used within the Quality Control Laboratory. This includes supporting all technical developments within EML’s laboratory as well as third party contracting activities to ensure operation in accordance with the requirements of the departmental Standard Operating Procedures and cGMP.
Responsibilities:
1. Ensure Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Eisai Corporate expectations.
2. Lead the Qualification and Validation of EML QC equipment, processes and systems to ensure performance in line with EML procedures, GMP and GAMP guidelines for process, equipment and electronic systems.
3. Support the procurement of new equipment and providing forecast for new/replacement lab equipment/software.
4. Lead the maintenance of EML procedures supporting Qualification and Validation ensuring they are current with updated requirements for Qualification and Validation and cGMP, cGxP expectations.
5. Lead and complete method transfer projects with third party approved contract laboratories as required.
6. Support QC team members with training and education on use of specialist QC equipment as required.
7. Ensure user access to systems is maintained in line with procedures and support is provided to facilitate the set up and change management of system data to ensure continuous system availability and functionality.
Your Skills:
8. Strong knowledge of pharmaceutical Quality Control equipment and electronic system qualification, validation and method transfers.
9. Excellent communication and good people management skills to support progression of technically led projects internally and externally.
10. Ability to understand and analyse user requirements to facilitate changes and system improvements.
11. Working knowledge of electronic systems, CSV and GAMP requirements.
12. Good understanding of the requirements of data integrity and application to system management.
13. Working knowledge of Quality Control Systems and analytical software and electronic Quality Systems.
14. Thorough understanding of GMP Guidelines and Regulations.