Senior Analyst, Quality Control

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 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 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.

Job purpose

The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).

Duties and responsibilities

• 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
• Participate on projects in the area of focus related to process improvement
• 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
• 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 assigned

Knowledge, 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

Problem Solving:

• Recommends changes and requests investigations where required.
• Any deviations to procedures or systems are brought to the Management’s attention with logic, data and corrective measures

Qualifications

• Bachelor’s Degree in Chemistry, or related discipline
• 3-5 years experience in the pharmaceutical industry in a Quality Control Laboratory.
• Knowledge of Pharmaceutical Manufacturing and Packaging an asset
• Demonstrated technical writing skills
• Well developed interpersonal and teamwork skills
• Demonstrated leadership skills including coaching and training

Working conditions

• Ability to work under stressful conditions and changing priorities
• Ability to support work in other shifts
• Numerous and varied responsibilities demanding attention and detail
• Working in general office and laboratory environments