Responsibilities: Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports. Generate Downstream Bridging document, ensuring full alignment with Process Science (PS) ...
Responsibilities and Requirements: 2-5 Years of Experience within Commissioning Activities within Engineering. Working Cross Functionally (Vendor Interaction Experience is a Plus). Heavy Documentation Experience with Excellent Oral and ...
Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and intern...
Responsibilities: Member of clinical research team responsible for data management activities across multiple trials. Main responsibilities include design of Case Report Forms, development of edit check specifications, creation of test s...
submissions and internal knowledge sharing. Requirements: BS, or MS in chemistry, biochemistry, pharmaceutical sciences...
Responsibilities: Expert on manufacturing process flow and design transfer, Lead manufacturing fixture development, process development and qualifications, lead process development and optimization of critical fabrication. maintain manuf...
submissions and internal knowledge sharing. Requirements: BS, or MS in chemistry, biochemistry, pharmaceutical sciences...
in the pharmaceutical/life science industry. Extensive knowledge and experience executing validation protocols...
Responsibilities: Heavy Documentation role doing batch review, quality doc approval Documentation exp. on Resume review of quality documents, batch release experience or lab notebook (design, manufacturing or release). Experience in non-...
Responsibilities: Help in developing, producing, and characterizing lipid based nucleic acid formulations with targeting moieties for innovative drug products to support multiple internal programs. The incumbent should be familiar with a...