Job Description The purpose of this job is to work in a cross functional team to support the Microbiology Quality Control testing function, ensuring compliance with cGMP.
Conducting microbiology analysis including bioburden testing, endotoxin testing, microbial identification, Biological Indicator testing, BacT/ALERT testing, sterility checks, and growth promotion of media as required.
Carry out environmental monitoring including viable and non-viable particulate monitoring and water and gas system monitoring in cleanroom areas in the manufacturing facility.
Reading of test plates, data review, trending.
Performance of laboratory sampling and testing.
Provide support and subject matter expert knowledge in investigations associated with deviations.
Provide assistance to other members of staff where required.
To work on own initiative and be capable of developing solutions to problems as part of a team.
To participate in the preparation of protocols and reports.
To document data as dictated by current client policies and procedures.
Meet with the client project team lead daily and provide updates.
Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
To revise SOPs as required by the Lead Analyst or client representative.
To review analytical data for GMP compliance Qualifications A degree in Microbiology or a related discipline is required with a minimum of 1- 3 years' within a pharmaceutical regulatory environment Ability to work independently and meeting established timelines.
Academic and or practical EM experience is a requirement for this role Knowledge of cGMPs Excellent communication skills both written and verbal Customer focus; takes personal responsibility for speed; quality and accuracy of delivery Self-motivated and ability to work under pressure Successful track record in achieving goals as part of a team within a growing, dynamic environment Demonstrated adaptability and flexibility to support a growing organisation. Good understanding of requirements for working in a GMP environment.
Ability to quickly learn new processes.
Ability to communicate clearly and to form strong working relationships with colleagues.
Ability to work in a lab environment with some supervision and be capable of developing solutions to problems as part of a team.
Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements.
Ability to switch priorities at short notice is desired.
Good team player, organised, accurate, have strong documentation skills.
Passionate about quality and customer service.
Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges.
Additional Information Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services.
It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 61,000 staff across a network of more than 1000 independent companies in over 61 countries and operating more than 900 laboratories.
Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
Eurofins PSS Insourcing Solutions is a global, award-winning insourcing solution.
We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities.
We ensure a strategic, long-term service commitment that delivers value directly at the client' site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility.
If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions is your gateway to a future where innovation, collaboration, and success converge.
Join us in a world where excellence knows no boundaries!