Duration: 6 months contract (extension is possible)
Working: Full time (40 hours)
Our client is one of the leading companies in biopharmaceutical industry, commited to promote new ways of treatment in serious diseases by developing innovative immunotherapies.
As a Technical Writer you will be responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution
-Document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement
-Performing compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations
-Supporting Global Product Development & Supply organization for our client's electronic document management system
-Synthesizing feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes.
-Minimum of a Bachelors degree
-5+ years’ experience in the Biopharma/Pharmaceutical industry
-Excellent technical writing skills
-Expert in MS Office and Collaboration applications
-In depth knowledge of cGxP requirements (includes GMP, GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement
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