Production Officer

2 weeks ago

India Right Advisors Private Limited Full time

Designation : Officer/Senior Officer Production FDA

Educational Qualification: B. Pharma/M. Pharma

Skill Set Required : Knowledge of chemical processes, FDA requirements, cGMP,

ERP, Lab Analysis, Communication Skill, Shift handling

Experience : 4 Years holding valid FDA Manufacturing chemist approval.

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.

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