Officer/ Sr. Officer Production
1 week ago
Job Description:
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.
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