Senior Analyst, Quality Control
SUN PHARMA
Date: 11 hours ago
City: Brampton, ON
Contract type: Full time
Job Purpose
The main responsibility for this position is to perform method development, validation, verification and transfer activities to support Quality Control and Operations (Development).
Duties And Responsibilities
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
Office based role
Direct reports
The main responsibility for this position is to perform method development, validation, verification and transfer activities to support Quality Control and Operations (Development).
Duties And Responsibilities
- Development and Validation of test methods within the QC lab using HPLC, GC and other instrumental techniques with the goal of updating and improving existing methods
- Perform Assay, Impurities & Residual solvents method validation study.
- Prepare method validation, method verification and method transfer protocol and report.
- Perform assay, related substance and wet chemistry tests for bulk, in-process, cleaning swab solution & exhibit/stability sample.
- Support junior analysts for their troubleshooting in different analytical instrument and data analysis.
- Provide support in new Product Launch, Compendial Updates & Quality System
- 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
- Assist senior associate to complete OOS, OOT, CAPA, Lab Event & UPD in TrackWise.
- Initiate, and follow through with actions required to close Change Controls
- Other lab duties as assigned by the manager
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
- Bachelor’s Degree in Chemistry, or related discipline
- Minimum 6-8 years of Analytical method validation experience in the pharmaceutical Industry.
- Knowledge of Extractable & Leachable, Nitrosamine, IVRT, LCMSMS & GCMSMS would be an asset
- Demonstrate technical writing skills, leadership skills (including coaching and training)
- Expert knowledge and understanding of analytical chemistry and instrumentation
- Proficiency with analytical instrumentation (HPLC, GC, V-Vis, pH meter, viscometer, Karl Fisher apparatus, IR etc.)
- 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 skills
- Advance ability in investigative techniques to troubleshoot analytical problems
- 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
Office based role
Direct reports
- NA
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Human Resources Generalist (AutoPlanet Brampton)
Performance Auto Group,
Brampton, ON
1 week ago
DescriptionPosition at Performance Auto Group Drive for Excellence Looking to join a fast-paced and an ever expanding organization? Be a part of our dynamic team at Performance Auto Group! Our Employee Services team is currently seeking a Retail Dealership Human Resources Generalist to join our AutoPlanet Used Car Dealership in Brampton, Ontario.The Human Resources Generalist (HRG) is responsible for performing...
Electrical Designer
EXP,
Brampton, ON
1 week ago
Job DescriptionSenior Electrical Designer!Brampton, ONAt EXP, we’re driven to provide innovative solutions for the world’s built and natural environments. As a team of engineers, architects, designers, scientists, creators, and a community of professionals, we bring diverse and talented people together to solve the world’s most complex challenges. Here, you join a team that leverages differences, harnesses their entrepreneurial spirit in...
Inventory Control Clerk
IKO North America,
Brampton, ON
2 weeks ago
IKO Industries Ltd. is a market leader in the manufacturing of roofing and building materials. IKO is a Canadian owned and operated business with production facilities worldwide and has many years of unparalleled success in the roofing materials industry. Quality, integrity, and trustworthiness are the values that underlie this success, and we have built this company by hiring people who...
