Analyst, Calibration
Brampton, OntarioJob purpose
The main responsibility of this position is to maintain GMP compliance of all instruments and equipment assigned to the Metrology group.
Duties and responsibilities
- Calibration/verification of instruments and equipment (such as GC, HPLC/UPLC, balance, pipette, UV-VIS spectrophotometer, IR spectrophotometer, thermometer, ovens, viscometer, invitro diffusion system, Karl Fisher titrator, pH/conductivity meter and dissolution system)
- Review and revise calibration/verification procedures to remain compliant
- Work with internal customers to assist in the introduction of new equipment. This will include working with vendors as well as groups purchasing equipment.
- Creating test methods for verification of new equipment
- Interpretation of test results and creating a plan if additional testing is required
- Coordinating with third party contractors for repair and calibration appointments
- Complete all documentation following GMP guidelines and company SOPs
- Complete training as required by training matrix
- Document all steps performed in case of a non-conformance investigation
- Complete requirements as related to Corrective and Preventive Actions (CAPA’s)
- Initiate Change Controls providing steps required and including other stakeholders
- Participate in Internal, Customer and Regulatory Audits.
- Order supplies required by group
Additional responsibility (Only applicable to customer facing roles)
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
- B. Sc. Chemistry or equivalent
- 3-5 years of laboratory experience
- Understanding of SDS for safe handling of chemicals used in testing
- Ability to communicate with other team members on group tasks
- Ability to diagnose equipment issue and decide if the issue can be resolved internally or requires external service. All steps will be documented and procedures must be followed.
- Working knowledge of Empower software
- Experience with Waters and Agilent HPLCs/UPLCs
- Experience with Agilent GCs
- Multitasking ability including changing priorities as required
- Document report writing
- GMP guidelines
Working conditions
- Daily tasks are performed in a laboratory environment. While performing tasks there will be exposure to chemicals and their associated odours used in product manufacturing and testing
- There is occasional exposure to higher than normal noise levels.
- Overtime is required that may include coming in early, working late or weekends
- Prior notification of overtime may not be possible and will be distributed to all group members
Physical requirements
NA
Direct reports
NA
About Us
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.
Our Values
Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.
How We Work
With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.
Benefits
-
Health & Wellness
We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
-
Financial
We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
-
Life, Work & Family
We provide work-life benefits that support our employees beyond their workday.
-
About Us Learn more
-
Career Areas Learn more
Jobs for You
- Intern, Human Resources Brampton, Ontario
- Analyst, Calibration Brampton, Ontario
- Coordinator, Regulatory Affairs (Contract) Brampton, Ontario
You have no recently viewed jobs.
You have no saved jobs.
Get Job Alerts
Sign up below to receive job alerts, our monthly newsletter, and advice from our recruiters straight to your inbox.
