Overview

  • Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
  • Our Brampton location is presently looking for a Quality Compliance Officer to join our Quality Assurance Department.
  • The incumbent will participate in the maintenance of a site wide quality program to meet Taro, Canadian and FDA GMP requirements.  This position is to perform manufacturing GMP oversight in order to support activities related to manufacturing and packaging pharmaceutical products at the Taro manufacturing facility.  The incumbent will provide oversight for on-the-floor activities in order to enforce the developed and implemented systems and procedures to ensure quality product is manufactured and packaged right first time and ensure that Taro operations are fully in line with regulatory expectations.

Principal Duties and Responsibilities :

  • Perform GMP oversight of the manufacturing activities
  • Provides knowledge sharing with manufacturing staff in order to establish/strengthen a culture of Quality and increase the right first time (coaching)
  • Provide regular scheduled shop floor GMP training to manufacturing staff to facilitate continuous improvement and right first time
  • Present strong QA oversight, and promote right first time quality for manufacturing and packaging activities
  • Provides guidance to the GMP training program to ensure adequate orientation and ongoing training is performed and documented to meet GMP requirements as well as elevate and standardize site wide GMP expectations.
  • Oversee the review and trending of manufacturing and packaging Quality data and metrics, including the monitoring and reporting of Key Performance Indicators.
  • Monitor Issuance, review and archival of production log books
  • Maintain and trend right the first time metrics for logbook and batch record review.
  • Perform real time review of production logbooks and follow up on document corrections
  • Perform real time review of Manufacturing batch records and follow up on document corrections
  • Release/Reject of Bulk manufacturing lots after thorough review documentation and completion of checklists
  • Perform proactive shop floor GMP assessments in order to reduce incident and deviation
  • Support the self inspection program
  • Prepare and enhance standard operating procedures and perform training
  • Coordinate and facilitate priorities, organizes weekly events to meet requirements and communicate effectively to key areas.
  • Provide support for Regulatory Inspections
  • Assist with Non-Conformance Investigations for shop floor areas
  • Initiate Hold/Reject Notification requests for product, systems and materials.
  • Review and approve Change Controls and Operations procedures
  • Assist Manufacturing Oversight Senior Manager with other duties as required.
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate Non-Conformance Incident reports as required
  • Perform QA review of Event Reports related to production floors and provide follow up recommendations.
  • Redline/revise SOPs to promote continuous improvement for shop floor
  • Initiate, and follow through with actions required to close Change Controls related to shop floor activities
  • Participate in Internal, Customer and Regulatory Audits.
  • Other duties as assigned

Knowledge, Skills and Abilities:

  • Bachelor of Science in Chemistry or related field
  • Minimum 10 years  experience in Quality Assurance related to manufacturing operations
  • Minimum 8 years experience working in a regulated quality environment in a USFDA pharmaceutical manufacturing setting
  • Demonstrated collaborative approach leading cross-functional teams, including effective negotiation and resolution of conflicts
  • Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
  • Ability to effectively analyze problems, to exercise sound judgment and make sound timely decisions
  • Preferred experience with liquids, cream and ointments
  • Sound knowledge and application of Health Canada, FDA and ISO regulations
  • Strong attention to detail (documentation review)
  • Strategic orientation with  lean approach
  • Sense of urgency, results and performance driven
  • Excellent organizational and time management skills and ability to multi-task
  • Excellent communication (written and verbal), negotiation, coaching, interpersonal, investigation, technical writing and interpersonal skills
  • Knowledge of pharmaceutical standards; transfer guidelines, validation requirements
  • Problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
  • Problems associated with dealing with individuals from departments, and working on various functions

To apply for this job please visit the following URL: https://www.taro.ca/en/job-details/457 →


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