Senior Scientific Officer-

3 weeks ago

Dera Bassi, India Panacea Biotec Full time

Position Title : Senior Scientific Officer/Scientific Officer- Quality Control- Electrophoresis and Chromatography lab

Educational Qualification : M.Sc. / M.Tech -Biotechnology/ Microbiology

Experience : 3 to 7 years



Job Summary

Senior Scientific Officer/Scientific Officer- Electrophoresis and Chromatography Lab (Quality Control) shall be responsible for ensuring the quality and efficacy of vaccine formulations at Vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for overseeing the operation of HPLC, Weighing Balance operation, pH meter, Operation of densitometer, operation of tube heating block, testing of CRM-197 Protein by HPLC and SDS Page etc.


Responsibilities:

1. Hands on Knowledge for operation of HPLC, Weighing Balance operation, pH meter, Operation of densitometer, operation of tube heating block, etc.

2. Hands on experience for testing of CRM-197 Protein by HPLC and SDS Page.

3. Hands on experience for testing of Free Carrier protein by HPLC on HiBTT, HiBTi conjugate and Pneumo conjugate

4. Hands on experience for testing of Molecular Size by HPLC on HiBTT, HiBTi conjugate and Pneumo conjugate

5. Ensure online documentation as per good documentation process.

6. Experience on Method validation for different products

7. Experience for evaluation of LOD/LOQ for rinse samples

8. Verification of Packing and consumables for Production department

9. Testing of Raw material and release.

10. Review of Analytical data’s tested for HPLC and Raw materials.

11. Proficient in analytical procedures and analytical method validations

12. Monitoring of ongoing testing activities on shop floor.

13. Issuance of Reference standards, Retention sample and Stability Sample.

14. Review of analytical data, capability to analyze the raw data of HPLC, GC, spectrophotometer etc JOB DESCRIPTION Name of Dept. Quality Control – Electrophoresis and Chromatography Lab.

15. Right allocation of manpower in shift working and monitoring of assigned task with optimum output.

16. Ensure Quality and quantity of consumables, Solutions with adequate usage & timely delivery to different manufacturing processes.

17. Right & Timely Documentation including SOPs, Change Controls, Deviations, Incidents, CAPA, Risk Assessments, in preview of PQS in view to regulatory guidelines & expectations.

18. Ensure zero non- compliance & zero data integrity in documentation.

19. Ensure regular maintenance of all equipment`s of production by engineering to achieve zero-breakdown.

20. Coordination with intra departmental activities in compliance to support/execution.


Competencies Required:

1. Effective Communicator.

2. Motivate Team and Enable High Performance.

3. Effective Performance Reviews of the Team and their Training.

4. Must understand the team needs at the time testing, sample preparation

5. Must understand Sterile Operations, Scientific practices, analytical techniques & process criticalities of Vaccine manufacturing.

6. Analytical approach – Good in trend analysis, data evaluation & process calculations.

7. Adequate, Timely & Quality deliverance/ Output within stipulated timeframe.

8. Thorough understanding of PQS & its compliances with risk based approach.

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