Description:
Duties and responsibilities
- Perform Assay, Impurities, In-Vitro & Cleaning method development and validation study using HPLC, GC and other instrumental techniques.
- Ensure all routine analysis related with bulk, finished product, exhibit and stability sample are completed within deadline
- Perform method verification, compendial update & method transfer activities.
- 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.
- 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.
- Generate, gather and analyze data for reporting purposes.
- Complete all GMP Documentation correctly and in a timely manner.
- Ensure OOS/OOT & CAPA’s are completed within timeline.
- Initiate, and follow through with actions required to close change controls.
- Participate in Internal, customer and regulatory audits.
- Maintain a clean laboratory environment and ensure that safety regulations are followed
- Complete all training assignment and maintain personal training records.
- Flexibility to work shift schedules when required
- Support in peer reviewing all analytical data
- Support new product launch.
- Other duties as assigned by manager
Qualifications
- Bachelor’s degree in chemistry / pharmacy, or related discipline
- 1-3 years’ method validation, method verification & method transfer experience in the pharmaceutical laboratory.
- 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-Vis, IR, HPLC, GC, UPLC etc.)
- Knowledge of applicable software including LIMS, Empower and MS Office
- Sound knowledge and application of Health Canada and FDA regulations
- Excellent written communication and report writing skills
- Strong organizational skills and ability to multi-task; detail oriented
- Advanced ability in investigative techniques to troubleshoot analytical problems
- 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
- Knowledge of Pharmaceutical Manufacturing and Packaging would be an asset
- Apply: email resume# trilliumpharma-at-gmail.com
- trilliumpharma@gmail.com