Executive - DSQA

Enzene Biosciences Ltd; Maharashtra; On-site; INR 600,000 - 850,000; Full time

Job summary

Enzene Biosciences is seeking an Executive to perform routine shop floor rounds on the manufacturing and warehouse floors to ensure product quality. The role includes ensuring compliance against findings, line clearance for bio bulk batches, and monitoring upstream/downstream processes in a biopharma setting.

Ideal candidates hold MSc/MPharma or related postgraduate qualifications with 2–6 years of Biopharma/Biotech experience, and preference for biosimilar or biologics exposure.

Qualifications

• MSc, M Pharma or related postgraduate degree.
• 2–6 years of experience in Biopharma/Biotech.
• Experience in Biosimilar or Biologics preferred.

Responsibilities

• Routine shop floor rounds in manufacturing and warehouse to ensure consistent quality of product.
• Follow up for shop floor compliance against findings in manufacturing and warehouse.
• Line clearance of batches manufactured in Bio bulk manufacturing and Dispensing activity of Raw/Consumable materials for Bio bulk manufacturing.
• Monitoring of upstream and downstream process.
• Review of Facility management trends.
• Review of Technology Transfer Documents of all the new products introduced in Unit I Bio bulk manufacturing at Enzene Bioscience.
• Review of Master Formula Record
• Review of study protocol and reports of bio bulk manufacturing and MSAT
• Review of audit trail of manufacturing equipment's and follow up for compliance.

Skills

Shop floor rounds

Quality assurance

Biopharma knowledge

Education

MSc / M Pharma or related

Job description

• Routine shop floor rounds in manufacturing and warehouse to ensure consistent quality of product.
• Follow up for shop floor compliance against findings in manufacturing and warehouse.
• Line clearance of batches manufactured in Bio bulk manufacturing and Dispensing activity of Raw/Consumable materials for Bio bulk manufacturing.
• Monitoring of upstream and downstream process.
• Review of Facility management trends.
• Review of Technology Transfer Documents of all the new products introduced in Unit I Bio bulk manufacturing at Enzene Bioscience.
• Review of Master Formula Record
• Review of study protocol and reports of bio bulk manufacturing and MSAT
• Review of audit trail of manufacturing equipment's and follow up for compliance.

Company: Enzene Biosciences

Designation: Executive

Office Location: Chakan, Pune

Primary Responsibilities:

• Routine shop floor rounds in manufacturing and warehouse to ensure consistent quality of product.
• Follow up for shop floor compliance against findings in manufacturing and warehouse.
• Line clearance of batches manufactured in Bio bulk manufacturing and Dispensing activity of Raw/Consumable materials for Bio bulk manufacturing.
• Monitoring of upstream and downstream process.
• Review of Facility management trends.
• Review of Technology Transfer Documents of all the new products introduced in Unit I Bio bulk manufacturing at Enzene Bioscience.
• Review of Master Formula Record
• Review of study protocol and reports of bio bulk manufacturing and MSAT
• Review of audit trail of manufacturing equipment's and follow up for compliance.

Educational Qualifications Preferred

• MSc, M Pharma, or Post graduation i related field

Required Work Experience

• Industry: Biopharma/ Biotech
• Years of experience: 2 to 6 years
• Experience in Biosimilar or Biologics prefered.