Senior Executive - Validation Lab

Enzene Biosciences Ltd; Pune District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

A leading biotechnology company in Pune District is seeking a qualified individual for a Quality Control position. Candidates should hold an M.Sc., M.Pharm, or Master's degree in Biotechnology or related fields, with 5-8 years of hands-on experience in relevant techniques like CEX-HPLC and ELISA. Responsibilities include method validation, data review, and ensuring compliance with cGMP. Proficiency in MS Word and PowerPoint is also required, along with strong analytical and problem-solving skills.

Qualifications

• Hands-on experience in techniques like CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis.
• 5-8 years of relevant experience.
• Proficient in computer skills, including MS Word and PowerPoint.

Responsibilities

• Perform method validation, stability sample analysis, and review of analytical data.
• Prepare and review specifications, STPs, TDS, SOPs, COA, MVP, MVR, and MTR.
• Coordinate with vendors for external calibration and collaborate with QC personnel.
• 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 QMS activities.
• Ensure QC lab compliance with current cGMP.

Skills

CEX-HPLC

SE-HPLC

ELISA

Capillary Electrophoresis

MS Word

PowerPoint

Education

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

Job description

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).

Educational Qualifications

M.Sc., M.Pharm, or a Masterís degree in Biotechnology or relevant subjects.

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.