Designation : Officer/Senior Officer Production FDAReporting to : Production ManagerEducational Qualification : B. Pharma/M. PharmaSkill Set Required : Knowledge of chemical processes, FDA requirements, cGMP, ERP, Lab Analysis, Communication Skill, Shift handlingExperience : 4 Years holding valid FDA Manufacturing chemist approval.Budget: 8 to 10 LPANOTE: FDA CERTIFICATE IS MANDATORYKey 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 activitiesEnvironment 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.
Job Title
Production Officer