The role of the QC Documentation Reviewer is to ensure 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). Documentation Reviewer is responsible for reviewing raw data and various technical reports with minimum supervision.
Main Job Duties:
- Review raw data generated by laboratory operations, analytical reports and CofAs with minimum supervision. 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.
- Review instrument qualification data package.
- When required, review protocols, reports, and change controls. Consult regarding changes to existing production processes and the impact to product quality and stability.
- Verify the integrity and traceability of all data generated and reported. Notify direct manager regarding omissions, incomplete testing results or other irregularities.
- Perform technical review of QIR/OOS/UR/CAPA/Deviation investigations, ensuring through facilitation that the writing, review and approval of investigation documentation are accurate, complete and performed according to internal SOP.
- Identify errors and discrepancy in methods, SOPs and other technical documents.
- Other tasks as assigned.
- Minimum B.Sc. in Chemistry, Biology, Life Sciences or other related field and/or equivalent experience. 2+ years of pharmaceutical industry experience, preferably in a bioanalytical laboratory.
- Good understanding of common analytical technologies (e.g. HPLC, GC, UV spectroscopy, titration) Basic understanding of cGMP, ICH and FDA requirements.
- Ability to meet deadlines and prioritize. Good interpersonal and oral communication skills are required.