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Drug Substance Process Validation Specialist (REF7750G)

Company: Jobleads
Location: Cambridge
Posted on: May 3, 2021

Job Description:

Drug Substance Process Validation Specialist (REF7750G) 123 Bay St, Cambridge, MA 02139, USA Contract Company Description ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes. Job Description Drug Substance Process Validation Specialist(6-month contract, fully remote) Coordination of drug substance process validation activities across several manufacturing modes. Scope: Management of the execution of a process validation master plan. Author validation protocols and guide the execution of validation studies related to the initial startup of cGMP operations and/or change controls, as well as process qualifications. Support the assessment of deviations, investigation, and change controls for validation activities in a regulatory setting. One resource to focus on overall strategy, project management, as well as designing some complex studies, the other resource to focus on document writing. Oversee PPQ strategy and project management. Develop impurity clearance protocol, execution support. Develop in-process hold (microbial and phys/chem) study protocol, execution support. Develop mixing study protocol, execution support. Support leachable and extractables assessment. PPQ protocol and batch record review. Bulk intermediate investigation and CAPA support. Additional Information All candidates must be legally eligible to work in the USA. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*** Drug Substance Process Validation Specialist (REF7750G)

Keywords: Jobleads, Cambridge , Drug Substance Process Validation Specialist (REF7750G), Other , Cambridge, Massachusetts

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