About this role
R&D Analyst
Duties & Responsibilities:
- Support in validations of Tech-Transfer products, preparation of protocols and reports.
- Handling of incidence, OOS and OOT.
- Support in validation of analytical methods for monitoring the specified quality of Formulations for Assay, Dissolution, Related Substances, Stability & Stability Indicating Methods, Content Uniformity, Forced Degradation, Excipient Compatibility.
- Preparation & review of departmental SOPs, Implementation of SOP & general QMS system through training.
- Should be able to plan and monitor routine analysis of trial batches, validation batches, stability batches and preparation of reports.
- To co-ordinate with Formulation team and QC to prepare the stability protocols for scale-up / Validation / Tech-Transfer batches.
- Support in compilation of protocols, methods, validation reports and stability reports in-line with CTD requirement.
- Good understanding guidelines for matrixing of Analytical method validations for cut off studies.
- Periodic Calibration of instruments & equipment.
- Hands on experience in handling all the analytical equipment like UV / HPLC / UPLC / GC/AAS
- Preparation and standardization of laboratory chemicals.
- Assist in the validation of manufacturing and analytical process and ensure that adequate collation and reporting of data is carried out.
- Ensure adequate and regular stocktaking of Laboratory Chemicals/reagents and wares.
Other Duties:
- As assigned by Assistant Quality Control Manager and Quality Manager
Qualifications
- B.Sc. Chemistry/ B.Sc. Biochemistry