Job Description

Department DetailsRole Summary

• Prior work experience in a cGMP regulated environment and troubleshooting manufacturing related issues.
• Prior knowledge in Drug Substance (or) Drug product in biopharmaceutical manufacturing processing is added advantage.
• Perform detailed and thorough investigation of the Deviations/OOT/OOS related to approved manufacturing process and Equipments involved for operations.
• Lead the Deviation investigation by facilitating discussions with relevant SMEs from all the relevant departments such as Manufacturing, RND, MSAT, Engineering and IA, Quality and collaborative partner.
• Actively participate in troubleshooting the complex issues in Manufacturing process.
• Participate in regulatory audits to present and walk auditors through the deviation investigation.
• Manage appropriate system to track status of open deviations and update routinely to Section Lead/ Head of the Site Investigation Team.
• Excellent communication skills, action oriented and ability to work well in fast pace, cross functional technical environment.

Key Responsibilities

• Prior work experience in a cGMP regulated environment and troubleshooting manufacturing related issues.
• Prior knowledge in Drug Substance (or) Drug product in biopharmaceutical manufacturing processing is added advantage.
• Perform detailed and thorough investigation of the Deviations/OOT/OOS related to approved manufacturing process and Equipments involved for operations.
• Lead the Deviation investigation by facilitating discussions with relevant SMEs from all the relevant departments such as Manufacturing, RND, MSAT, Engineering and IA, Quality and collaborative partner.
• Actively participate in troubleshooting the complex issues in Manufacturing process.
• Participate in regulatory audits to present and walk auditors through the deviation investigation.
• Manage appropriate system to track status of open deviations and update routinely to Section Lead/ Head of the Site Investigation Team.
• Excellent communication skills, action oriented and ability to work well in fast pace, cross functional technical environment.

Educational QualificationsRequired Education Qualification: B.Pharma
Required Experience: 1 - 5 years

Biocon