Scientific Writer & Reviewer
Scientific Writer and Reviewer is responsible for ensuring that all documentation related to the successful release of laboratory work is complete and conforms to all Diteba Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs). He /She is responsible for writing and reviewing various technical reports and raw data generated by internal departments with minimum supervision.
- Review and prepare protocols, reports, SOPs, change controls, OOS/UR/OOT investigations and deviation investigation reports with minimum supervision. Consult regarding changes to existing production processes and the impact to product quality and stability.
- Provide technical support to reviewers and participate in departmental meetings and also work as designate in the absence of the QC-Review Manager.
- Review raw data generated by analytical development laboratory and analytical reports and C of A’s. Ensure test methods, protocols and applicable SOPs have been followed during the testing. Follow up to ensure that all necessary corrections are executed in accordance with cGMP standard.
- Verify the integrity and traceability of all data generated and reported. Notify direct manager regarding omissions, incomplete testing results or other irregularities.
- To comply with all Employee Health and Safety requirements and participate in EH&S training programs.
- Other tasks as assigned
- Minimum B.Sc. in Chemistry, Biology, Life Sciences or other related field and/or equivalent experience. 3+ years of pharmaceutical industry experience, preferably in an analytical development or QA function.
- Basic understanding of common analytical technologies (e.g. HPLC, GC, UV spectroscopy, titration) Basic understanding of cGMP, ICH and FDA requirements.
- Excellent computer proficiency with MS office programs. Ability to meet deadlines and prioritize. Excellent written and oral communication skills. Proficiency with the English language required.