Associate, Site Investigation Team

Site Investigation Team

Deviations Investigator is responsible for performing deviation investigation and documenting the process and the outcome of the investigation. This includes but not limited to root cause analysis, appropriate Corrective and Preventive Actions (CAPAs) definition and product impact assessment. This role requires the individual to coordinate and collaborate with internal stakeholders such as Subject Matter Experts (SME’s) from Manufacturing, Manufacturing Science and Technology (MSAT), Engineering, Validation, Quality and any other relevant functions during the course of the investigation. The individual needs to have strong technical writing skills and excellent oral presentation skills. This position reports to Senior/ Section Lead /Manager of the Site Investigation Team (SIT).

Job Requirements:

• 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.
• Bachelors/Masters (Biochemical Engg/ Biotechnology /Food Tech) (or) Master of Science (Biochemistry/ Chemistry/ Microbiology)