18 Sep
|
MSN Group
|
Hyderabad
18 Sep
MSN Group
Hyderabad
Role & responsibilities
Executive / Senior Executive QC (Biotechnology/Biosimilars)
Company: MSN Laboratories
Location: Pashamylaram, Telangana
Experience: 3–7 Years
Function: Quality Control – Biologics/Biosimilars
We are looking for an experienced Executive / Senior Executive – Quality Control with relevant experience in Biotechnology, Biologics or Biosimilars. The candidate will be responsible for analytical testing, documentation, investigations and compliance with cGMP/GLP requirements.
Key Responsibilities
- Perform QC analysis of biological/biosimilar products, raw materials, intermediates and finished products.
- Hands-on experience in analytical techniques such as HPLC/UPLC, SEC-HPLC, ELISA, SDS-PAGE, CE-SDS, Western Blot, UV-Vis and protein assays.
- Perform potency/bioassay testing, where applicable.
- Execute testing as per approved SOPs, specifications and analytical methods.
- Prepare and review analytical data, worksheets, test reports and QC documentation.
- Handle OOS/OOT, deviations, CAPA and laboratory investigations.
- Support method validation,
method verification and analytical method transfer activities.
- Ensure compliance with cGMP, GLP, GDP and ALCOA+ / Data Integrity requirements.
- Coordinate with QA, Production, R&D; and other cross-functional teams.
- Support internal, customer and regulatory audits.
- Ensure timely completion of QC testing and maintain laboratory compliance.
Education M.Sc. / M.Tech / B.Tech / M.Pharm in Biotechnology, Biochemistry, Microbiology, Pharmaceutical Analysis or relevant discipline.
Desired Candidate Profile
- 3–7 years of relevant experience in QC of Biologics/Biosimilars/Biotechnology products.
- Robust hands-on experience in protein characterization and analytical testing.
- Good knowledge of GMP, GLP, OOS/OOT, CAPA and Data Integrity.
- Good documentation, communication and problem-solving skills.
- Candidates with experience in biopharmaceutical/biologics manufacturing environments will be preferred.
📌 Executive / Sr Executive -Quality Control (Biosimilars) (Hyderabad)
🏢 MSN Group
📍 Hyderabad