Job Description
About the job
This role is based on site in Edinburgh at our pharmaceutical manufacturing plant.
In this role you will be required to, in alignment with the cGMP, CFR 21 part 11, data integrity, good documentation requirements, applicable laws and regulations, and Global and site policies and procedures perform Pharmacopeial methods for absence of specified organisms, coordinate and perform disinfectant efficacy studies and perform analysis in support of the manufacture of pharmaceuticals and fine chemicals with a focus in microbiology analysis, water testing and related work n support of batch release and environmental monitoring. .
Your responsibilities
To assist in the implementation of continuous improvement activities to improve efficiency and quality of the services provided.
To assist in the monitoring and trending the QC performance KPI’s related to your function/department.
To identify and escalate any potential compliance issues to the Microbiology group leader, Head of QC or Quality Director in a timely manner.
To operate documented systems to ensure that duties are performed to cGMP and maintain cGMP standards.
·Perform the validation testing for specified organisms testing as per harmonised European Pharmacopoeia (Ph.Eur.) <2.6.13>, United States Pharmacopoeia (USP) <62> and Japanese Pharmacopoeia (JP) <4.05> and Brazilian Pharmacopoeia 5.5.3.1.3, and USP <60>(Microbial Examination of Non-sterile.
Perform microbiology validation work as required by the Microbiology group leader or nominated deputy
Ensure that the working area is maintained in a clean and organised fashion to meet the expectations of a cGMP laboratory
To ensure that all related documentation meets current cGMP requirements for control of documents and control of records.
What you need for the role
Degree level in Microbiology or closely related subject
Previous experience in a cGMP laboratory and Clean room environment
Previous experience in specified organism testing
Experience working using the asceptic technique
Why Apply
We are a global leader in the development and manufacturing of active pharmaceutical ingredients, with expertise in highly regulated and complex chemistries. You may know us as Macfarlan Smith. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.
As well as a competitive salary, our employees enjoy a comprehensive benefits package.
Job Types: Full-time, Fixed term contract
Salary: £34,000.00-£38,000.00 per year
Benefits:
- Additional leave
- Bereavement leave
- Canteen
- Company pension
- Cycle to work scheme
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Free parking
- Life insurance
- On-site parking
- Sick pay
- Store discount
Schedule:
Supplemental pay types:
Ability to commute/relocate:
- Edinburgh: reliably commute or plan to relocate before starting work (preferred)
Application question(s):
- Have you worked in a cGMP environment before?
- Have you carried out testing of specified organisms before?
- Have you worked using aseptic technique before?
Work Location: In person
Application deadline: 13/09/2023
Reference ID: MBFTC
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