What is in it for you:
Three weeks Vacation + Personal Days
Professional growth and Advancement
Our client is presently looking for an Analyst, Quality Control, Development to join their QC department.
**** must have method validation on impurities experience ****
****must have method development****
The main responsibility for this position is to perform method development, validation and transfer activities to support Quality Control and Operations (Development).
Principal Responsibilities :
- Develop and validate methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods.
- Develop and validate cleaning validation methods as required.
- IV Drug release testing for product comparison.
- Perform process validation and cleaning validation testing.
- Perform method transfer activities.
- Support new product introduction.
- Product, method and raw material trouble shooting.
- Collaborate with other departments to proactively build quality into the processes and systems.
- Create and revise QC procedures as required.
- Provide support for internal and Regulatory Inspections.
- Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
- Complete all GMP Documentation correctly and in a timely manner.
- 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.
Knowledge and Skills
- Bachelor’s Degree in Chemistry, or related discipline
- 3-5 years experience in the pharmaceutical industry in a Quality Control Laboratory.
- must have method validation on impurities experience
- Knowledge of Pharmaceutical Manufacturing and Packaging an asset
- Demonstrated technical writing skills
- Well developed interpersonal and teamwork skills
- 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
- Advanced ability in investigative techniques to troubleshoot analytical problems