1. Ensuring the SOPs of products, materials, processes, equipment’s and system for the effi-cient functioning of related fields.
2. Test, evaluate and verified of all laboratory samples including lab batch, pilot batches, scale-up batches, stability samples, dissolution profile, solubility profile and comparative study using analytical instruments and established analytical procedures and tech-niques.
3. Ensure that all specifications, test methods and ARD procedures are appropriate and approved.
4. Maintain the testing systems in accordance with the Quality Standards, including all the necessary validation, calibration and cleaning.
5. Arrange all logistics like chemicals/ reagents, equipment, furniture, stationeries for smooth operation of ARD activities through maintaining liaison with all other related departments / person if necessary.
6. Evaluate the analytical method development and validation of Assay, Dissolution, Relat-ed Substances for solid and liquid dosage forms.
7. Ensure the procedure for method transfer and verification. Specially, analytical method transfer report, analytical method validation & verification protocol and report.
8. To supervise the management of the laboratory functions in accordance with SOPs.
9. To check / supervise all analytical works at every stage so that GMP / GLP and others regulatory requirements are fulfilled.
10. Ensure the proper preparation of all relevant documents / reports like SOP, different type form, export dossier etc. according to the regulatory requirements.
11. Investigate and handle of ’out of specification’ (OOS) result & perform the corrective ac-tion.
12. Ensure the proper and complete documentation of IQ, OQ and PQ of all ARD instru-ments.
13. Ensure proper and timely (after led time) disposition of all products through maintaining liaison with all other relevant department like Planning / FRD.
14. Check and examine chemicals, reagents, glassware, other tools and sensitive equip-ment’s and take measures to ensure reliability of the test results and to avoid break-down/complication.
15. Design and deploy effective training and skill enhancement curriculum and ensure pro-fessional performance and productivity for the analytical staff.
16. Ensure and monitor Good Laboratory Practices (GLP) and safety regulations to avoid un-foreseen incidents.
17. To supervise and distribute the daily works of subordinates and manage departmental administration.
18. Preparation of technical specification for procuring analytical instruments.
19. Establish and maintain quick and effective system for archiving/ preservation/retrieving of all relevant documents/ records as per GMP/GLP and others regulatory guideline.
20. Any other relevant duties as per agreed work requirement of the ARD from time to time.