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.