Practitioner / consultant
Microbiologist, QC Environmental Monitoring Richmond Hill
About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Under the direction of Laboratory Supervisors, the Microbiologist, EM will conduct various Environmental monitoring activities of utilities and premises within the Apotex group of companies. Other Microbiological Laboratory related duties such as processing of Environmental monitoring samples will also be conducted as required.
The Microbiologist, EM is responsible for generating accurate results while following GMP requirements in accordance with established compendial and in-house methods.
- Displays an understanding of and proficiency in Environmental monitoring and other Pharmaceutical Microbiology Lab related activities.
- Good understanding of compendial requirements pertaining to microbiological test activities. Works collaboratively with microbiologists, EM and the supervisor in troubleshooting obstacles.
- Demonstrates a good working knowledge of LIMS, SAP & Microapps transactions as required.
- Assists in the execution of protocols and preparation of trend reports.
- Ensures sampling is conducted in a timely manner to meet required turn-around times.
- Accountable to maintain compliance with assigned training plan pertinent to job functions.
- With a keen eye for detail, performs verification of microbial test results and calculations generated by peers. Reviews work for accuracy and alignment with procedures.
- Ensures timely communication of any out of specification and out of trend investigations to supervisor.
- Ensures issues regarding methodology and instrumentation are communicated to Leadership.
- Coordinates and monitors the availability of Environmental monitoring supplies and equipment.
- Promotes a positive work environment, motivating peers.
- Ensures that all work is performed in compliance with current Good Manufacturing Practices, Good Laboratory Practices, Standard Operating Procedures, established safety standards, compendial and other regulatory requirements.
- Performs all work in support of our Corporate Values.
- All other duties as assigned
Knowledge, Skills and Abilities
- Good Computer skills; prior experience with LIMS would be an advantage.
- Able to interpret results and perform work with minimal supervision.
- Good verbal and written communication and interpersonal skills.
- Detail oriented with excellent problem solving skills.
- Strong understanding and utilization of GMP and GLP.
- Proven organizational and time management skills, as demonstrated through previous work and/or experience.
- Job will require repetitive, routine Environmental monitoring activities. In addition, job will require work inside a manufacturing area or mechanical room for sample collection.
- Job will involve shift rotations, Evening or Night shift with weekend coverage as required
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers 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.