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Microbiology Lead, Compliance & Continuous Improvement

Date: Feb 18, 2021

Location: Richmond Hill, ON, CA, L4C 5H2

Company: Apotex

 

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.

 

Job Summary

Responsible for generating accurate results while following GMP requirements.  Responsible for conducting analysis and providing technical support for Microbiological testing on products (Commercial, R&D development and Stability), Bacterial Endotoxin Testing, Sterility Testing, Environmental Monitoring, Antimicrobial Effectiveness Testing and Bacterial Identification in accordance with established compendial and in-house testing methods, while working under minimal supervision. 

In addition, as a Microbiologist, Lead, QS8, the incumbent will coach, mentor and assist in the technical development of junior Microbiologists and provide support and troubleshooting expertise in microbiological analysis as required.

As required, the Microbiologist, Lead will work in a leadership role overseeing a team responsible for initiating, tracking and facilitating/supporting  timely closure of Change Controls.

The Microbiologist, Lead will also be responsible for review and approval of documentation for the Microbiology department.    Responsibilities will also include completion of special test requests and execution of compliance and process improvement projects in compliance with established SOP, Good Manufacturing Practices and Good Laboratory Practices.

The Microbiologist, Lead, QS8, will also act as a Qualified Trainer for the Microbiology department and will be responsible for providing front line support for technical and troubleshooting with regards to investigations, methodology and instrumentation.

As required, responsible for the Supervision of laboratory personnel and approving Water (Purified Water and Water for Injection), Raw Materials and Finished Products in accordance with all in house, compendia, and regulatory requirements.

Job Responsibilities

  1. Displays strong technical skills and proficiency in Microbiological Testing of Non-Sterile Products, Bacterial Endotoxin Testing, Sterility Testing, Environmental Monitoring, Antimicrobial Effectiveness Testing, Bacterial Identification and other Pharmaceutical Microbiology Lab related activities. Provides support in the operation of instrumentation and equipment.
  2. Initiates, directs and leads projects in support of the microbiology department:

Designs and drafts protocols recommending appropriate course of action.  Executes or oversees the execution of protocols by Microbiologists.

Collaborates and liaises with department Managers, key customers, suppliers and employees in the identification, prioritization, selection and execution of projects  

  1. Recognizes OOS or Out of Trend results and completes Laboratory Investigations
  2. Interprets and documents all test results, calculations and observations and completes comprehensive reports as required. Supports leadership teams in preparation of trend reports and metric development.
  3. Utilizes sound technical expertise to troubleshoot on more complex, problematic products by serving as a technical resource within the microbiology team.
  4. Provides technical support/coaching and/or training to other Microbiologists where appropriate.   Assists laboratory management in the development of all levels of microbiologists.

Acts as the primary qualified trainer for microbiology department. Assist management in qualifying new microbiologist for proficiency testing.

Coaches/mentors and assists in the technical development of microbiologists.

  1. As required, supports the initiation, tracking and facilitating/supporting  timely closure of Change Controls
  2. Prepares weekly schedules and task assignments to support Manufacturing activities and ensures deadlines are met under minimal supervision.
  3. Ensures the proper disposal of Biological hazardous material, waste solvents and orders any media or laboratory supplies, as required.
  4. Performs the role of document reviewer, as outlined below:
  • Reviews raw material and Finished Product data.  Ensures all results conform to current specifications, Good Manufacturing Practices, in-house, compendial and regulatory requirements.   
  • Prepares documentation for shipment of RH and OSD products tested by 3rd party labs
  • Reviews Third Party results and Laboratory documentation to ensure completeness and accuracy of reporting and reviews supplier C. of A. when required. 
  1.  In the absence of the Supervisor, would schedule own work and that of junior

 Microbiologists.

  1.  In the absence of the Supervisor, issues Lab Investigation, VIC reports and QMS   Deviation investigations.
  2. Directly involved in on site customer and regulatory audits, acting as a front line subject

 matter expert during audits/inspections and through data support.

  1.  As required, works in partnership with Managers overseeing a team responsible to initiate, track and support/facilitate  closure of Change Controls for the department.
  2. Maintains compliance to Good Manufacturing Practices, Good Laboratory Practices and regulatory requirements.
  3. Responsible and accountable for compliance with all aspects of the Ontario ccupational Health and Safety Act, Canadian Biosafety Guidelines as well as Apotex’s Health and Safety policies, and Safe Work Procedures (SWPs).
  4. Performs all work in support of our Corporate Values.
  5. Performs other duties as assigned

Job Requirements

  • Education
    • Bachelor of Science from a recognized educational institution in Microbiology or a related field with a minimum of 5 years relevant experience in a Pharmaceutical Microbiology Lab environment; OR Community College diploma in a related discipline with preferably 6 years relevant experience in a Pharmaceutical Microbiology Lab environment

 

  • Knowledge, Skills and Abilities
    • Excellent working and theoretical knowledge of automated laboratory instrumentation including:  Bacterial Identification Systems (Biolog, Omnilog or Vitek), Autoclave, Sterility Test Isolator, Bacterial Endotoxin Test unit (Endoscan).          
    • Ability to interpret results and perform work without direct supervision
    • Excellent verbal and written English communication skills; clear and concise technical  writer.
    • Excellent problem solving skills
    • Excellent knowledge and understanding of GMP/GLP as applied to a laboratory setting
    • Ability to share knowledge with team members and across Quality Control and Quality Assurance departments.
    • Excellent computer skills with software packages such as Excel, Word and laboratory software packages
    • Proven organization and time management skills, as demonstrated through previous work and/or educational experience.
    • Strong leadership skills with a drive for results
    • Supports the promotion of a positive, inclusive work environment; motivating peers.
    • In depth understanding of compendia requirements, GMP regulations and standards for pharmaceutical testing.



Experience

    • 5 to 6 years relevant experience in a pharmaceutical lab environment

 

 

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.