Qc and Lab Equipment Specialist

4 days ago

Glasgow, United Kingdom FPSG Connect Full time

**Description**:

- Responsible for coordinating testing and release of all raw materials that are brought on-site. This will involve ID testing on all containers of new pharmaceutical excipients, to ensure suitability for use in GMP production.
- Release of materials to compendial standards will be performed.
- Some cleanroom work may be required as part of the sampling procedure for incoming materials.
- This role extends to inspecting incoming manufacturing components and equipment, and performing related documentation checks as part of their release for use.
- Occasional outsourcing of compendial testing will be required. This role will liaise with external labs to support the process and will ensure timelines are adhered to.
- This role will also involve a lot of inter-departmental work, particularly between QC, Warehouse and Production functional areas.
- This includes maintaining effective relationships with external testing providers to ensure testing deadlines are met.
- Perform regular checks upon stability cabinets, fridges and
- Organize and perform maintenance and calibration of laboratory
- Ensure completion and filing of relevant certificates/documentation is performed in accordance with
- Compile and monitor trends from stability
- Excellent written and verbal communication skills, as well as effective organizational skills are a must.

**Qualifications/Experience**:
Degree-level qualification in a chemistry-related discipline.

**OR** equivalent professional experience in a materials control role.

Knowledge/understanding of Ph. Eur., USP/NF, BP and JP pharmacopoeial testing requirements.

Experience of working within a GMP environment.

Experience of managing raw materials testing projects to ensure tight timelines are always met, so as to ensure material availability for use in our GMP production suite.

Experience of performing FTIR analysis and general wet chemistry analysis.

Experience of using Oracle ERP software would be desirable.

**Roles/Responsibilities**:

- Managing timelines for material sampling, analysis and release for use.
- Managing expectations of Project Management, Warehouse and Production staff, and ensuring suitable timelines are followed for incoming material testing and release for use by the Production team.
- Some work within a Grade D cleanroom environment will be necessary when taking samples of materials for testing.
- Wet chemistry
- Pharmacoepial ID Testing
- Inspection of all incoming vials, stoppers and overseals for imperfections that could affect manufacturing work.
- Documentation checks for all incoming equipment to be used in the Production suite.
- Frequent use of Oracle ERP software to release materials and equipment for use.
- Schedule and perform maintenance of laboratory equipment to ensure it is operational at all times.
- Respond to ever-changing project timelines to ensure manufacturing work does not halt.

**Next Steps**:
**Equal Opportunities**:
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.

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