Executive – Quality Control (QC)
Location: Pune, Maharashtra, India | Employee Type: Permanent | Department: Quality Control
Company Overview:
Join a leading biopharmaceutical organization focused on the development and analytical evaluation of biologics and therapeutic proteins. Our QC team ensures CGMP compliance, method validation, and reliable laboratory operations.
Role Overview:
We are seeking a QC Executive with hands-on experience in analytical testing, method validation, and stability studies. The role involves supporting day-to-day laboratory operations, preparing analytical documentation, coordinating calibration activities, and ensuring regulatory compliance.
Key Responsibilities:
Perform method validation and verification for drug substance (DS), drug product (DP), and in-process samples.
Conduct stability studies, IRS qualification, and biosimilarity testing.
Prepare and review analytical documentation: Specifications, STPs, TDS, SOPs, COAs, MVP, MVR, and MTRs.
Coordinate with vendors for external calibration and internal teams for in-house calibration and verification of lab instruments.
Manage lab materials, chemicals, standards, kits, and consumables, ensuring proper stock control.
Maintain laboratory equipment, instruments, and usage logbooks.
Support analyst qualification and training of MVL personnel.
Track, investigate, and follow up on QMS activities.
Ensure laboratory compliance with CGMP guidelines.
Adhere strictly to safety protocols.
Perform additional tasks as assigned by the reporting manager.
Technical Skills Required:
Hands-on experience in analytical techniques: CEX-HPLC, SE-HPLC, ELISA, HCDNA by RT-PCR, Maurice, SOLO VPE, HCP, Peptide Mapping, Glycan Analysis, and Capillary Electrophoresis.
Knowledge of method validation, verification, and stability study execution.
Qualifications & Experience:
M.Sc., M.Pharm, or Master’s degree in Biotechnology, Biochemistry, or related fields.
2–5 years of relevant hands-on experience in QC analytical operations for biologics or therapeutic proteins.
Soft Skills:
Strong attention to detail and organizational skills.
Effective communication and teamwork abilities.
Commitment to quality, compliance, and safety standards.
Why Join Us:
This role provides exposure to cutting-edge analytical techniques, CGMP-compliant laboratory practices, and opportunities to develop professionally within a collaborative environment.
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