Job Description

1. Hands on industrial experience in Biotech/ Biologics industry on Raw/ Packaging Material Testing.
2. Basic Knowledge/ Hands on experience in handling of equipment’s pertaining to RM/PM testing including but not limited to HPLC/GC/UV-visible Spectrophotometry, FTIR, Polarimeter, Refractometer, Autotitrator, TOC analyzer, Weighing balance, pH/ conductivity meter, Melting range apparatus, Viscometer.
3. Familiar with the basic cGMP systems including but not limited to sample management, OOS/OOT, Documentation control, Change Control, Audits, Deviation & CAPA Management.
4. Timely sampling & testing of Raw/Packaging/ Consumable materials as per Pharmacopoeial/In-house procedures.
5. Perform Daily sampling & testing of Utility samples with online documentation & trending.
6. Preparation of SOP’s/ STP’s/ equipment URS/ Qualification/ Study protocols/ reports pertaining to RM/PM section
7. Perform daily calibration/ verification/ requalification of analytical equipment’s as per the approved procedures & calibration/ verification frequency with online documentation.
8. The candidate should be conversant with Quality module of SAP and LIMS system. Timely Updation of RM/PM/CM and water analysis results in SAP and LIMS system.
9. The candidate should be conversant procedure for procurement of chemicals/ Reagents/ consumables and maintain their inventory records.
10. To Ensure cGMP compliance in laboratory and ensure that the laboratory is always maintained in audit ready status.

Work Experience

2 to 4 years

Education

Masters in Chemistry or Analytical Chemistry

Competencies