Title:  Manager - 1

Responsibilities

Lead process development (as either an individual contributor or technical leader of junior level scientist / technicians) for new immediate release and modified release solid oral dosage, soft gelatin capsule to facilitate technology transfer.

Plan scale-up/down batches in manufacturing area and oversee the batch executions with the responsible project scientist / manufacturing team.

Perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product / process development and improvement projects.

Act as internal / external subject matter expert (SME) for process related technical issues and provide technical support to Technical Operations, manufacturing, Quality, Cross-functional Team.

May supervise and mentor team of junior level and technicians in the designs, execution and interpretation of experiments.

May lead and / or Collaborates with multidisciplinary teams to resolve complex product / process development issues and respond to internal and external audits.

Generate accurate, reliable data by following established procedure and practice. Record, tabulate, summarize, interpret, report and publish study results.

Develop and maintain department standard operating procedures.

Co-ordinate with QA/QC/Store/Eng./Manufacturing Department for smooth functioning of MSTG activities.

To do the documentation as per cGMP/SOP/BMR/Qualifications as per GDP.

To implement the corrective and preventive action as and when required for compliance.

To handle and solve day to day issues and problem related to product and productivity.

To report any deviation and abnormality of any type as well to participate in incident investigation.

Perform other work assigned by Department Head.

To perform the DTC Job Role for Department (Preparation of Curriculum SOP, Facilitating of Training, ILTC punching in LMS, Revision of Curriculum, Deactivation of old version curriculum, Addition and removal of curriculum, waive off training)