Job Information
Sun Pharmaceuticals, Inc Senior Analyst, Quality Control in Canada
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, Taros world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our companys 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 (CAPAs)
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 Managements attention with logic, data and corrective measures
Qualifications
Bachelors 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
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.