Senior Executive - Validation Lab

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

Job summary

Enzene Biosciences Ltd. in Pune seeks an experienced QC professional to perform method validation, stability analysis, and review analytical data.

You will prepare and review specifications, STPs, SOPs, COAs, MVPs, MVRs, and MTRs while coordinating calibration activities with vendors and QC teams. The role requires hands-on experience with CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis, along with 5–8 years of relevant work in a GMP environment.

Qualifications

• Hands-on experience in techniques such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis analysis.
• 5-8 years of relevant experience.

Responsibilities

• Perform method validation and stability analysis; review analytical data.
• Prepare and review documents (specifications, STPs, TDS, SOPs, COA, MVP, MVR, MTR).
• Coordinate external calibration with vendors and in-house calibration with QC.
• Manage QC materials (chemicals, standards, kits, consumables).
• Maintain laboratory equipment and instruments.
• Train QC staff and conduct analyst qualifications.
• Initiate and track QMS activities.
• Ensure qc lab compliance with cGMP.

Skills

MS Word

PowerPoint

Tools

CEX-HPLC

SE-HPLC

ELISA

Capillary Electrophoresis

Job description

Roles & Responsibilities

• Perform method validation, stability sample analysis, and review of analytical data.
• Prepare and review documents, including specifications, Standard Test Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR).
• Coordinate with vendors for external calibration and collaborate with QC personnel for in-house calibration and verification of laboratory instruments and equipment.
• Manage QC materials, including chemicals, standards, kits, and consumables.
• Maintain and manage laboratory equipment and instruments.
• Conduct analyst qualifications and provide training to QC employees.
• Initiate, investigate, and track Quality Management System (QMS) activities.
• Ensure QC lab compliance with current Good Manufacturing Practices (cGMP).

Experience

• Hands-on experience in techniques such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis analysis.
• 5-8 years of relevant experience.

Soft Skill Competencies

• Proficient in computer skills, including MS Word and PowerPoint.