Executive / Sr Executive -Quality Control (Biosimilars)

Role & responsibilities

Executive / Senior Executive QC (Biotechnology/Biosimilars)

Company: MSN Laboratories
Location: Pashamylaram, Telangana
Experience: 3–7 Years
Function: Quality Control – Biologics/Biosimilars

Job Description

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.
• Strong 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.