Microbiologist

Pharmaceutical Sciences (PharmSci) is responsible for the design and development of synthetic routes, preclinical and phase I/II formulations, encompassing both small molecules and new modalities such as mRNA and oligonucleotides, across the whole range of AstraZeneca’s therapeutic areas.

Within Early Product Development and Manufacture (EPDM) in Gothenburg, Sweden, the manufacturing unit is accountable for delivering a vast portfolio of early investigational medicinal products. We have a wide range of manufacturing assets in three separate manufacturing facilities, supplying different types of clinical trial material to studies across the globe.

About the position
We are now seeking a new member to join our fantastic team, based at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work. Within the EPDM manufacturing unit, in the GMP (Good Manufacturing Practice) arena, you will make an important contribution in delivering clinical results in the development of new medicines.

This role is focused on environmental monitoring of the multipurpose GMP facilities and support to the manufacturing within the field of microbiology/hygiene. Therefore, knowledge within microbiology is a requirement for this role. In addition, experience of GMP purified water/water for injection systems is a merit, as accountabilities within these areas are included.

Responsibilities
Working in the role as Scientist/Senior Scientist in EPDM and PharmSci, you will be part of an amazing group of skilled and driven colleagues who truly embrace team spirit, who you will exchange knowledge and collaborate with on many levels in various contexts. This role provides excellent opportunities for your professional development, and possibilities to take on further accountabilities in line with your personal growth.

Your main accountabilities/responsibilities:
• Rapidly develop strong competence within relevant areas of responsibility and build credibility and ability to drive improvements and interact with stakeholders locally and globally.
• Work with practical hands-on processes in our GMP facilities, planning and performing hygiene and water sampling, and coordinate accordingly with QC Microbiology laboratory.
• Compile and evaluate microbiological results in periodic trend and review reports.
• Support with microbiological expertise in risk assessments and validation activities related to facility, equipment, and cleaning.
• Lead deviation investigations related to EM (environmental monitoring) and water result excursions, advising on corrective and preventive actions (CAPA).
• Support introduction and maintenance of new technology (EM LIMS) and sampling equipment with regards to microbiological aspects.
• Execute internal hygiene inspections and carry out basic GMP hygiene training sessions.
• Have a strong competence within documentation to be able to perform risk assessments, deviation documentation including CAPA, author SOPs, write reports and change controls, and other guidance documents in accordance with GMP quality systems.
• Monitor, secure and follow up on regulatory requirements according to GMP
• Ensure that SHE (Safety, Health and Environment) and GMP standards are upheld and ensure AZ Policies and Standards are understood and followed.
• Be entrepreneurial and drive initiatives to further improve flexibility and productivity, resulting in improved processes or increased value for our customers and patients.

Your profile
Do you have the essential qualifications for these roles?
To be successful in this role, we believe that you have a MSc in Microbiology or similar, or experience of cGMP within the pharmaceutical industry in combination with knowledge within the field of microbiology. If you have previous experience in working with hygiene sampling and work with water systems, this will be an advantage.

The perfect candidate would be a Scientist/Senior Scientist with excellent collaboration, communication, and planning skills with a strong sense of responsibility, team work and delivery focus. You are able to work independently and manage a wide range of specific tasks without losing focus, and you are able to prioritize workload and adjust priorities. Strong verbal and documentation skills in English is a requirement.

About the organisation
This position is a consultant assignment for 1 year at AstraZeneca in Göteborg. During this time you will be employed by QRIOS Life Science & Engineering.

QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER.