Job
Description
We are hiring Assistant Manager-Process Engineering for our client a specialized Active Pharmaceutical Ingredients (APIs) manufacturing, marketing, and service organization. Designation : Assistant Manager – Process Engineering Location : R&D Jigani (Requires travel among our cross functional units) JOB DESCRIPTION: · Perform and lead risk assessment exercises in support of Active Pharmaceutical Ingredients 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. · Provide process technical expertise for requirements, design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities. · Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis, and process modeling. · Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub-teams. Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety. Qualifications: B.Tech – Chemical Engineering Experience – Minimum 4-6 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 Immediate Recruitment.Please send your profile to hrdgradus@gmail.com or whatapp profile to 9886775176 Show more Show less
