Scientist – Early Product Development and Manufacturing
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What you will do:
As part of the EPDM manufacturing unit, you will work in a GMP (Good Manufacturing Practice) environment, contributing to the delivery of clinical results. Your role will focus on the manufacturing of drug product, with responsibilities including timely manufacture of various drug products, working with practical hands-on processes in our GMP facilities, monitoring regulatory requirements, supporting documentation activities, and driving initiatives to improve flexibility and productivity. As we are investing in innovative technology, among others within Continuous manufacture, we need to expand knowledge and competence in this area. Depending on prior experience and interest this role could be more adapted to this area.
About randstad life sciences
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.
Deadline: 2025-01-23, selection and interviews will be ongoing. For more information: Please contact Katan Ali, katan.ali@randstad.se
Accountabilities include:
• Work with practical hands-on processes in our GMP facilities following manufacturing batch records and perform transactions in material management systems.
• Assume responsibilities toward timely manufacture of various drug products in line with the plans agreed within EPDM and surrounding stakeholders.
• Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
• Rapidly develop strong competence within relevant process technologies and build credibility and ability to drive and secure product establishment, scale-up and clinical manufactures.
• Support documentation activities, e.g. by authoring manufacturing batch records, taking part in deviation investigations, authoring SOPs, and other guidance documents, change control processes etc.
• Assess records and report manufacturing and validation data accurately 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 shorter lead times or increased value for our customers and patients.
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