Senior Executive – Quality Control (QC)
Location: Pune, Maharashtra, India | Employee Type: Permanent | Department: Quality Control
Company Overview:
Join a leading biopharmaceutical organization committed to the development, analysis, and quality assurance of therapeutic proteins and biologics. Our QC team ensures compliance with CGMP standards, supports method validation, and maintains analytical excellence across all laboratory operations.
Role Overview:
We are seeking a Senior Executive – QC with hands-on experience in analytical method validation, stability studies, and biosimilarity assessments. The role involves planning and performing analytical tasks, managing lab operations, coordinating with vendors, 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 analyses.
Prepare and review analytical documents such as Specifications, STPs, TDS, SOPs, COAs, MVP, MVR, and MTRs.
Coordinate with vendors for external calibration and with internal teams for in-house calibration and verification of lab instruments and equipment.
Manage labware, chemicals, standards, kits, and consumables, ensuring proper stock control.
Maintain laboratory equipment, instruments, and usage logbooks.
Conduct analyst qualification and provide training to MVL personnel.
Initiate, investigate, and track QMS activities.
Ensure laboratory compliance with CGMP guidelines.
Adhere strictly to safety protocols and workplace safety standards.
Perform other tasks 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.
Strong proficiency in method validation, verification, and stability studies.
Knowledge of biosimilarity testing and analytical documentation standards.
Qualifications & Experience:
M.Sc., M.Pharm, or Master’s degree in Biotechnology, Biochemistry, or related fields.
6–9 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 team collaboration abilities.
Commitment to quality, compliance, and continuous improvement.
Why Join Us:
This role offers exposure to cutting-edge analytical techniques, CGMP-compliant processes, and opportunities to contribute to the development of high-quality biologics in a collaborative environment.
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