Assistant Manager- QC Analytical

Enzene Biosciences Ltd; Pune District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A biotech company in Pune District is seeking a professional for quality assurance tasks, including method validation and compliance with CGMP standards. The role requires 10 to 12 years of hands-on experience with analytical techniques like CEX-HPLC and ELISA. A Master's degree in Biotech or relevant subjects is mandatory. This full-time position is ideal for candidates looking to contribute to high-quality biotechnology projects.

Qualifications

• 10 to 12 years of relevant hands-on experience in quality assurance.
• Proficiency in various analytical techniques including CEX-HPLC, SE-HPLC, ELISA, and more.

Responsibilities

• Perform method validation and verification activities.
• Prepare documentation including Specification, STPs, and SOP.
• Manage calibration and verification of laboratory instruments.
• Ensure compliance with CGMP regulations.

Skills

CEX-HPLC

SE-HPLC

ELISA

HCDNA by RT-PCR

Capillary Electrophoresis analysis

Education

M.Sc. or M. Pharm or Master's degree in Biotech or relevant subjects

Job description

Role & Responsibilities

• To Preform method validation / Verification activity (DS, DP and in-process samples)
• To Preform stability, Qualification of IRS and biosimilarity activity.
• Preparation of documents like Specification, STPs, TDS, SOP, COA, MVP, MVR MTR etc.
• Coordination with vendor for external calibration and with MVL personal for in-house calibration and verification of laboratory instruments and equipment's.
• MVL labware's & materials (Chemicals, standards, kits and consumables) indent and control of stock.
• Maintenance and management of laboratory equipment and instruments and usage logbooks.
• Analyst qualification and MVL employees training
• Initiation, investigation and tracking of QMS activities
• Ensure MVL lab compliance in accordance with CGMP
• Strictly Adhere safety rules at workplace
• Any other task assigned by reporting manager

Experience

10 to 12 years of relevant hands‑on experience and proficiency in the tasks such CEX-HPLC, SE-HPLC, ELISA, HCDNA by RT-PCR, Maurice, SOLO VPE, HCP, Peptide Mapping, Glycan analysis and Capillary Electrophoresis analysis.

Qualification

M.SC., M. Pharm or Master degree in Biotech or relevant subjects

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance

Industries

Biotechnology