The Job profile (JD) for “Documentation Officer” is documented below.
Role
Task / Responsibility
Carry out
Preparation of Standard Operating Procedures (SOPs)
Carry out /Support
SOP life-cycle management
Carry out/Support
Preparation of Specifications & Standard Testing Procedures (STPs) of Raw Materials, including drug substance
Carry out/Support
Preparation of Specifications & Standard Testing Procedures (STPs) of Drug products
Carry out/Support
Preparation of Validation/Verification protocols & reports
Support
Preparation of Product specific test protocols & reports
Support
Preparation of Risk Assessment reports
Support
Preparation of Method Development Reports
Carry out/Support
Change- control for new equipment/department change of existing equipment
Carry out/Support
Documentation for sample dispatch for outsourced testing
Carry out/Support
Qualification documents – IQ, OQ & PQ
Carry out/Support
Stability Protocol (QA Protocol based)
Carry out/Support
Stability Reports (QA Protocol based)
Support
MFR – formatting as per template (document drafted by project scientist)
Required Education/ Qualifications/Skills
B. Pharm/M.Sc./M. Pharm with around 3-5 years of relevant experience in R&D-documentation in reputed pharmaceutical company
Required Competencies
Consistent performer
Good team-player
Good communication
...
