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Senior Analyst, Quality Control
1 month ago
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 assignedDevelopment 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 Create job rotation schedule and provide cross training for QC Analysts to ensure proficiency off staff in all QC programs Collaborate with other departments to proactively build quality into the processes and systems Creation and revisions to QC procedures as required 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 Health, Safety and Environmental requirements; Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements; Generate, gather and analyze data for reporting purposes; 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, and follow through with actions required to close Change Controls Participate in Internal, Customer and Regulatory Audits Other duties as assignedKnowledge, Skills and Abilities:
Expert knowledge and understanding of analytical chemistry and instrumentation Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC) Knowledge of applicable software including LIMS, Empower and MS Office Sound knowledge and application of Health Canada and FDA regulations 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. Excellent written communication and report writing skills Strong organizational skills and ability to multi-task; detail oriented Excellent problem solving and judgment Advance ability in investigative techniques to troubleshoot analytical problems Demonstrated ability to coach, mentor and lead Ability to work effectively in a team-based environment. Proficiency with applicable software (LIMs and Empower).Problem Solving:
Acting Senior Quality individual requires the execution of judgment, as well as understanding of when escalation is appropriate