Sr. Executive - Production GI ( Autoclave and preparation )

Role & responsibilities

• Applicant must have strong regulatory exposure & track record of having worked in regulated plants.
• Good exposure, experience and understanding in handling various sophisticated equipment ( Ex. Autoclave, ouch Sealing Machine, VHP Pass box, Mobile LAF Trollies, ETC
• Hands on experience for electronic QMS tools like Track wise and/or other, electronic SOP management tool, learning management tool (LMS/TMS) and other.
• Proper co-ordination and communication with other departments for better execution of documentation.  
• Preparation and Review of Machine URS/DQ/IQ/OQ/PQ protocol and execution of Re-qualification activities. Preparation and review of reports.
• Preparation and review of SOPs, BMR/BPCR.
• Handling batch documents for new product/pack presentation introduction like – Media fill, Scale-up/engineering, Exhibit, PPQ and commercial batches.
• Review and compliance of executed batch records and timely Closure to QA.
• Ensure online documentation with 99% RFT.
• Immediate information to superior in case of finding of any anomalies in process/batch records and any other documents.
• Active involvement in inspections preparation and maintain department Ready for Inspection in aspect of documentation.
• Any other assignments allocated by superiors.
• Must have SME knowledge  for Autoclave sterilization and Preparations  actives
• Good knowledge for Aseptic practice and clean room behavior.
• Responsible for timely closure of QMS action items, without extensions (min 95%) considering Deviations, Change controls, CAPA, internal audit &Inspections response actions and other.
• Responsible to prepare, update and maintain KPI details for production and communicate with defined frequency.
• Responsible for preparation and review of Risk assessment (QRM).
• Maintenance require stock of Materials to Avoid any production stoppes due to some ( Ex. Bowie dick kit, pouches google etc.
• Skill & Qualification:- 
  
• Minimum B. Pharm, M. Pharm, or M.Sc.
• Minimum 7 to 10 years of relevant experience required
• Autoclave Preparation, Compounding, and Manufacturing
• Aseptic Area Behavior
• QMS Compliance, Clean Area, GMP, GDP, Regulatory Knowledge, BMR, BPR, NVPC.