About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
- Under supervision of reporting manager developing, validating bio-analytical methods for the quantitation of drugs and metabolites in biological fluids involving medium to complex analytical techniques and applying the assay for the analysis of drugs and metabolites in biological fluids.
Job Responsibilities
- Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s, Standard Operating Procedures and in a consistent manner with current regulatory (DCGI- CDSCO, TPD, USFDA, TGA, ICH, GLP, EMEA) guidelines / established practices / expectations.
- To work with the assigned project lead for Bioanalytical method development, Bioanalyitcal Method validation and Routine batch sample analysis (RBSA).
- Involves in preparation of project specific solutions and sample preparation.
- Documents all the work and results of all assignments as required.
- Verifies and saves acquired results in Chromatography Data acquisition systems, when required.
- Performs Laboratory Investigation, when required.
- Operates general laboratory equipment and instrumentation systems and utilizes automated data collection/reporting systems.
- Performs raw data compilation, assists in project wrap-up.
- To ensure lab work area cleanliness.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Responsabilités inhérentes à l’emploi
Job Requirements
- Education
- Minimum Bachelor Degree holder in Pharmacy or Masters Degree in Science.
- Knowledge, Skills and Abilities
- Good knowledge of GLP requirements.
- Good skills in MS Office.
- Good in Communication skills.
- Flexible to work
- Strives to drive projects related to Bioanalytical effectively.
- Experience
- Minimum 2-4 years of experience in Bioanalytical.
Exigences liées au poste
At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
