Research Assistant – Quality and Compliance – Bioanalytical @ Intas
Research assistant post in quality and compliance division vacant at Intas. Intas Pharma hiring pharma candidates for research vacancies. Check out all of the details on the same below:
Job Title: Research Assistant – Quality and Compliance – Bioanalytical
No. of Posts: 02
Location : Ahmedabad(Gota)
Experience : 1 – 6 Years
Job Description:
1. Responsible for the effective implementation of GLP & ensuring its compliance level in the BA lab. This includes but not limited to ensuring GLP compliance in Freezer Room, Balance room (TICO), Extraction Lab, chromatography Lab and Stores.
2. Checking of instrument labels, completeness of logbooks of equipments and instruments and ensuring the instrument External calibrations are done before due date in Freezer Room, Balance room (TICO), Extraction Lab, chromatography Lab and Stores.
3. Checking of Refrigerator/Freezer in extraction Lab to check and discard the expired solutions and samples and checking of logbooks for respective entry of solutions and samples of Project/MV/MD.
4. Checking of pH meter in extraction Lab for internal calibration, checking of logbooks for respective entry of internal calibration and pH measurement of solution in Project/MV/MD and completeness.
5. Checking of water purification system
6. Checking of all centrifuges in extraction Lab and ensuring decontamination of centrifuge and its entry in logbook as per SOP and checking of logbook for completeness.
7. Checking of safety, cleanliness and hygiene in lab and checking of safety shower, Eye washer, stretcher and its log books for respective entry and completeness.
8. Ensuring External calibrations and Internal calibrations of pipettes and volumetric flasks are done before due date and checking of logbooks and forms for respective entry and completeness.
9. Ensuring all the activities of Balance room (TICO) and freezer room to be performed as per related BA SOPs.
10. Conduct the In-House system audit group wise/area wise and send the communication of the observation to the responsible person/group leader/ In-Charge and/or Head-Bioanalytical, and ensure the responsible person shall take the necessary action and respond within reasonable timeframe.
11. Monitoring and reporting the on-going activities of Freezer Room, Balance room (TICO), Extraction Lab, chromatography Lab and Stores to In-Charge/Head-Bioanalytical compliance GLP.
12. Ensure effective implementation of GLP and 21CFR Part 11 by checking of instrument labels, completeness of logbooks of equipments and instruments and ensuring the instrument calibrations are done before due date.
13. Arranging required data for sponsors audit and regulatory audit.
14. Providing support and tools to team members to succeed in the sponsors audit and regulatory audit.
15. To report the In-Charge and/or Head-Bioanalytical if any significant GLP/quality related issues are found in the department.
16. Responding to QA observations of system audit of the department.
17. To discuss the QA queries with In-Charge and/or Head-Bioanalytical/Group Leader(s) on regular basis in context of upgrading the GLP/systems.
18. Give training on various SOPs to trainee.
19. Develop self, and maintain knowledge in relevant field at all times.
20. Archiving of the HPLC, LC-MS/MS, Project Data and Validation Data.
21. Checking and tracking of data security of D drive of computer attached with LC-MS/MS systems in the department.
22. Checking of Silica gel of desiccators or vacuum tight box used for storage of hygroscopic/liquid standards in Balance room (TICO).
23. Checking of fume hood & fume arm in extraction lab.
24. Checking of Freezer Temperature data.
25. Ensure work is done as per OECD GLP principles.
Qualifications:
- UG -Any Graduate – Any Specialization, B.Pharma – Pharmacy
- PG – Post Graduation Not Required
