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Senior Analyst, Quality Control

Senior Analyst, Quality Control

SUN PHARMABrampton, ON, CA
30+ days ago
Salary
CAD23.38 hourly
Job description

Taro Pharmaceuticals is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in , Taro’s world class production facility is located in Brampton, Ontario, with a current team of over Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

Our reward packages have been designed to meet the needs of our diverse workforce and their families. For additional information visit :

Job purpose

The main responsibility for this position is to lead activities towards the maintenance of a site wide quality program to meet Taro, Canadian and FDA cGMP requirements. This position acts as an active influence towards elevating the quality practices and guidelines for product manufactured, packaged or tested at the Taro manufacturing facility.

This position may focus on either :

  • the coordination of activities for a designated team ensuring highest possible quality of work and schedule attainment (Team Leader) or,
  • project leadership of method development, validation and transfer activities to support Quality Control and Operations (Development).

Duties and responsibilities

Team Leader focus :

  • Lead a team of analysts to conduct GMP laboratory testing, providing coaching, Subject-Matter-Expertise and technical mentorship
  • Leads in the roll out of new laboratory requirements, business operation / processes, and technologies to the analyst team
  • Provide troubleshooting of test method and equipment issues
  • Responsible for the full-cycle of internal lab investigations including trending and preventative actions
  • Technical training of Analyst in analytical methods as well as on-boarding of new employees
  • In-process, bulk, FG, Stability, validation / verification and investigation sample testing.
  • Method transfer activities.
  • With the Quality Control Supervisor, lead meetings to determine priorities, coordinate the workload and communicate and seek agreement with team on group priorities.
  • Provide support for internal and regulatory inspections.
  • Recommend, design and deliver training targeted to ensuring technical capability of team as well as compliance with SOPs & Canadian and FDA cGMP and HS&E requirements.
  • Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
  • Other duties as assigned

    • Development focus :

  • Leads the Development and Validation of methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods
  • Development and validation of cleaning validation methods as required
  • IV Drug release testing for product comparison
  • Process Validation and Cleaning Validation testing
  • Method Transfer activities
  • New Product introduction
  • Product, Method and Raw Material trouble shooting
  • Lead projects in the area of focus related to process improvement
  • With the Quality Control Supervisor, leads meetings to determine priorities, coordinate the workload and communicate and seek agreement with team on group priorities
  • Act as Subject Matter Expert and provide technical assistance, coaching and guidance to team