Job Description

JOB DESCRIPTION

Perform and lead risk assessment exercises in support of API process scale up & validation activities. Collaborate with R&D to ensure successful API product development and technical transfer to Manufacturing. Coordinate Scale up & validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects. Maintain knowledge and comprehensive understanding of peptide regulations and current interpretations affecting equipment, product, and process. Scale up & Validation representative on site project team and resource to other departments for API product and process knowledge. Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs). Perform troubleshooting and investigation on unexpected issues. Own equipment-related deviations, CAPAs, and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis, and in development/implementation of countermeasure for quality, safety, environmental events. o Provide process technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities. o Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, dataanalysis, and process modeling. Active participation and engagement in the meetings and activities of the assigned process team andsafety/environmental sub-teams. Ensure process complies with current industry regulatory expectations, new regulations, and corporatepolicies and programs for Quality, Health and Safety & Environmental, Process Safety.
Qualification - B.Tech - Chemical Engineering

Experience - Minimum 3-4 years of relevant experience in API products.

Experiences in API Process Development & Scale up/ Process validation

Additional Skills/Preferences:

Strong written and oral communication skills Strong leadership and organizational skills Knowledge in managing multiple project objectives or assignments Technical Writing.
Job Type: Full-time

Pay: ₹50,000.00 - ₹60,000.00 per month

Benefits:

Provident Fund
Ability to commute/relocate:

Bangalore, Karnataka: Reliably commute or planning to relocate before starting work (Required)
Experience:

total work: 1 year (Preferred)
Work Location: In person