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Project Leader, Investigations (Contract for One Year)

Date: Mar 31, 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 Preparing the report for Laboratory related investigations for Raw Material, Dosage samples, Stability, Method Verification, Technology Transfer, Process, Cleaning Validation and Special Test Requests, while working under minimal supervision. 

Provides support and troubleshooting expertise for the laboratory investigations for Raw Material, Dosage, along with Process and Cleaning Validation samples, as required.  Assists with the training of Chemists when deemed required by the investigation outcome.  Responsible for the in time closure of CAPA and effectiveness check related to CAPA implementation.

Job Responsibilities

  • Collects information, prepare investigation plan, and completes laboratory related investigations with minimum supervision.
  • Interprets and documents all test results, calculations and observations and completes comprehensive reports as required.
  • Utilizes technical expertise to troubleshoot complex lab instrumentation and method problems that are identified during the laboratory investigations. Recommends solutions and works collaboratively with supervisor to resolution.
  • Provides technical troubleshooting support/coaching and/or training to other chemists where appropriate. Uses knowledge of cGMP to assess impact on compliance, provides recommendations on appropriate testing to Supervisor and works collaboratively for resolution.
  • Prepares weekly schedules and task assignments to support investigation activities and ensure deadlines are met, under minimal supervision.
  • For investigation purpose, performs the role of document reviewer, as outlined below:
    • Reviews lab data. Ensures all results entered in the laboratory investigations conform to current specifications, cGMP, in-house, compendia and regulatory requirements.  Verifies all calculations for mathematical and analytical accuracy.
    • Consults with supervisor on any issues of non-conformance and may recommend solutions to obtain results that are in conformance with testing procedures and cGMP.
    • Consults with department chemists to ensure that all necessary corrections are made to analytical reports and document requirements to ensure compliance with cGMP.
    • Review Third Party and Laboratory documentation to ensure completeness and accuracy when required.
  • Maintains compliance to all health and safety standards, Current Good Manufacturing Practices, Current Good Laboratory Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex's Health and Safety policies, and Safe Work Procedures (SWPs).
  • 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.

Job Requirements

  • Education

    • Bachelor of Science from a recognized educational institution in Chemistry or a related field with a minimum of 5 years relevant experience in a pharmaceutical lab environment. 

      OR

    • Community College diploma in a related discipline with preferably 6 years relevant experience in a pharmaceutical lab environment
  • Knowledge, Skills and Abilities

    • Excellent working and theoretical knowledge of automated laboratory instrumentation including HPLC, GC, Nasal Spray testing techniques, AA, UV, and Dissolution.
    • Excellent written and verbal English communication skills.
    • Ability to prepare laboratory investigation reports without direct supervision
    • Excellent knowledge and understanding of cGMP/cGLP as applied to a laboratory setting
    • Excellent problem-solving skills
    • Ability to share knowledge with team members and across QC.
    • Excellent computer skills with software packages such as Excel, Word and laboratory software packages.
    • Strong organization and time management skills, as demonstrated through previous work and/or educational experience.
    • Strong organizational skills with a drive for results.
    • In depth understanding of compendia requirements, cGMP regulations and standards for pharmaceutical testing.
    • Technology/Instrumentation (Type & Complexity)
    • Advanced knowledge of lab equipment and testing such as GC, HPLC and Nasal Spray Instrumentation, technology transfers, AA techniques, Related Compound, Residual Solvent, titrations, coloumetric limit tests, trace metal analyses, and complex wet chemistry involving extractions.

  • 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.

 

We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.

Other measures Apotex has put into place include (but are not limited to):

•        staggering employee shifts to reduce the size of work groups

•        modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines

•        robust self-assessment and screening tools

•        non-surgical masks for employees working in GMP areas

•        travel restrictions

•        work-from-home policy for all employees who can perform their roles remotely

•        strict visitor screening protocol

It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.

For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter