Job Description
We are seeking a skilled Technical Writer with a strong background in the biopharmaceutical industry to create and maintain essential documentation for manufacturing processes and quality systems.
Key Responsibilities:
* Experienced Technical writer.
* Execution of cleaning validation protocols.
* Experience on writing and approving Deviations/GMP.
* Technical writing experience in writing site reports.
* Assessment of CIP/SIP issues during study runs and close.
* Cleaning validation/SIP results reporting review beneficial.
* Generation of Summary Reports and strong quality background essential.
* Experience in continuing validation and generation of assessments.
Additional responsibilities include scheduling of Cleaning/SIP activities with Manufacturing, following all EHS/Safety SOP/Policies, actively looking for Continuous improvements, and an understanding of manufacturing and CIP/SIP Validation equipment.
Requirements
* Experience in QA Validation activities.
* Strong background in the biopharmaceutical industry.
* Project management skills desirable.