QC Equipment Specialist

SRG are recruiting for a QC Equipment Specialist for a leading life sciences company who are going through an exciting period of growth.

This is a great opportunity with an excellent salary and benefits on offer including flexi-time as well as a great opportunity for future development.

Responsibilities:

• To manage and co-ordinate the purchase, repair, service, calibration, qualification and validation of QC equipment and software according to defined procedures and protocols and in accordance with cGMP work practices, Quality standards and metrics.
• Ensure that Maintenance/Repair contracts are in place and up to date for each instrument
• Liaise with QC/Manufacture/Engineering to ensure that maintenance, calibration and qualification activities are performed in an efficient manner with minimum impacts on current activities
• Liaise with external contractors, internal engineering department and equipment users to minimise down time and ensure good performance of equipment at any time
• Ensure that the site induction for engineers is conducted to apply safety and quality rules at any time and be their point of contact.
• Review/approval of engineer documentation and record any relevant information in instrument log as per procedures
• Escalate any issue and raise any quality documentation (RFC, Deviation, Investigation, CAPA) and progress them with the support of Senior QC staff members where applicable.
• Track/trend maintenance activities
• Perform basic trouble shooting investigations or ask for SME support in order to facilitate discussion with engineers
• Ensure that Maintenance/Repair contract are in place and up to date for each instrument
• Liaise with approved and trained engineers for on-site and external work.
• Identify new instruments/instrument replacement needs and liaise with QC Team Leaders/QC Manager to ensure that they are aligned with current activities needs
• Validation, calibration and set up of equipment

Experience Required:

• Degree or equivalent in a relevant scientific discipline
• Experience within a QC laboratory working to GMP within a recognised quality system
• Ability to organise work within a busy laboratory with experience of writing URS, DQ/IQ/OQ documentation, PQ and DI documentation
• Knowledge of GMP guidelines, 21CFRpart11, Annex 11 and equipment regulations

This is a fantastic opportunity for an someone with extensive equipment management experience to work with a highly successful global company based in Central Belt of Scotland

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.