Officer/ Sr. Officer Production - FDA

Key Responsibilities:

·         To handle bulk manufacturing activities as well as to take trials related to formulations as and when required.

·         Compliance to FDA requirements from manufacturing perspective, including yield management.

·         Production, maintenance or any day-to-day activities related to bulk manufacturing in consultation with the stake holder or GSO / line manager

·         To ensure all the safety equipment, PPE’s are in place and are used during bulk manufacturing.

·         Monitoring and ensure all bulk manufacturing cGMP and GHK.

·         Ensure all bulk manufacturing to be done as per latest and approved TDS MOM

·         To ensure all manufacturing documents / formats are being used, filled properly as per SOP and well maintained.

·         Ensure all bulk testing carried out as per TDS and on time at process lab.

·         To verify adherence of the process to the RB product quality standards.

·         To verify all the checks are carried out timely and all control measures are in place.

·         To ensure all specification for bulk material are meeting the RB standard.

·         To conduct Minimum manufacturing standard audit and process audit for manufacturing and get close all gaps as per decided time line.

·         Lead process audit as per specified calendar and follow-ups to close all gaps.

·         Impart training to all manufacturing peoples on safety, Quality, SOP, MOM, MSDS, and Dispensing etc.

·         time to time.

·         Ensure only authorize person do bulk manufacturing as well analysis at process lab.

·         Monitor all manufacturing CIP process and adherence of SOP.

·         Investigation of all bulk related complaints, conduct RCA, provide and implementation of CAPA.

·         Review BMR and handover to QA.

·         Ensure all EHS standards and guidelines are followed at the shop floor.

·         Wastage analysis and action on high losses or gains

·         Ensure discipline, quality standards and productivity norms are maintained on the shop floor.

·         Ensure operators involvement by providing trainings and various other motivational activities.

·         To handle shift operation and other MFG and Packaging related activities

Environment Standard Roles & Responsibilities:

·         Understand all Env & Safety standards requirement of & Participate in relevant trainings to achieve working knowledge w.r.t Env & Safety standards.

·         Include requirement of Env & Safety standards while developing or reviewing respective area operational SOPs.

·         Identify and Understand Environmental Risks related to the profile of job role. 

·         Awareness of the environment's legal norms for the job role assigned. 

·         Report, investigate environment & Safety Incidents to identify CAPA.

Legal Requirement:

·         NA-

Competency Requirement:

·         Manufacturing FDA Chemist Approval.