Duration:
12 months
Job Description:
Our client is looking for a GMP Technical writer to help with batch record and protocol review and writing. This client would like this candidate to have GMP manufacturing experience, injectable manufacturing (or sterile manufacturing), cleaning experience in the development and manufacturing space. The candidate will be reviewing/authoring/drafting batch records based on formulation procedures, study protocols, SOP’s and tech transfer protocols. This candidate should have at least 5-10 years of experience in FDA related industry (pharma/bio). They also prefer a candidate that is well versed in Qualification Regulations such as ICH guidelines and ISO accreditation.
Candidates must display attention-to-detail, excellent technical writing skills, and a technical GMP understanding. Previous experience working directly with CDMO’s will be beneficial.
Skills:
GMP
Batch Record
Cleaning Validation
Sterile Manufacturing
Injectable Manufacturing
Education:
Science/Engineering BA/BS
NJ: GMP Technical Writer (234147)
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