Job Description
About the job
This role is based on site in Edinburgh at our pharmaceutical manufacturing plant. To perform all microbiology and environmental monitoring requirements 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.
Your responsibilities
To assist in the necessary improvements to obtain and maintain a well organised, flexible and efficient QC Microbiology department that consistently meets the business needs and customer requirements.
To perform analysis in support of the manufacture of pharmaceuticals and fine chemicals. Main focus areas: microbiological analysis, water testing and related work in support of batch release and environmental monitoring
To comply with all appropriate regulations, cGMP, CFR 21 part 11, data integrity, good documentation requirements and EHS requirements, controlled drugs regulations and all relevant global and site policies and procedures.
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.
To assist with the completion of deviations, CAPA, investigations, change controls
To operate documented systems to ensure that duties are performed to cGMP and maintain cGMP standards.
Perform microbiological, water sampling/testing and environmental monitoring analysis.
Support microbiology validation work.
Perform required microbiological analysis of stability samples
Reports any out of specification or anomalous results
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
Experience in Environmental Monitoring
Knowledge of micro techniques (Endotoxin by Turbidimetric analysis)
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 Type: Full-time
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 carried out the following Microbiology testing (Endotoxin and Bioburden (TAMC TYMC)
Work Location: In person
Application deadline: 31/05/2023
Reference ID: MB01