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Pharmaceutical Quality Assurance Specialist

2 months ago

Fall River, Massachusetts, United States Cipla Full time
Job Title:

Quality Assurance Production Lead

Job Summary:

The Quality Assurance Production Lead is responsible for ensuring product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs). This role requires a strong understanding of good manufacturing practices and good documentation practices.

Key Responsibilities:
  • Review and approval of batch manufacturing/packaging records
  • Release of raw materials, packaging materials, and finished products through approval of respective COA
  • Review and approval of engineering records, including temperature and humidity data calibrations, preventive maintenance records, pest control records, and contractor-related functions
  • Review and approval of manufacturing/engineering non-conformance, change controls, deviation investigations, and CAPAs
  • Reviews and approves manufacturing/engineering qualification documents
  • Provides daily/weekly updates to the shop floor and management regarding quality highlights/concerns
  • Creates lessons learned for training as a communication mechanism to shop floor personnel
  • Leads manufacturing quality associates on daily activities, including the assignment of weekly work schedules
  • Performs training and onboarding of QA associates to ensure they are qualified prior to beginning their daily functions
  • Acts as quality lead for all shop floor questions/concerns and acts as backup for shop floor QA associates
Requirements:
  • Bachelor's degree in pharmaceutical manufacturing, industrial management, or a related field of study from an accredited college/university
  • Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment
  • Understanding of machines used in pharmaceutical manufacturing
  • Effective interpersonal relationship skills and the ability to work in a team environment
  • Capable of conducting troubleshooting, investigations, and root cause identification and analysis
  • Proficient in computer skills and software applications, including Microsoft Office tools
  • Experience using SAP business system and applications is a plus
About Cipla:

Cipla is a leading global pharmaceutical company dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies.

Our company believes that our biggest assets are the employees who lead us to prosperity and growth in the future.

Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.