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Quality Validation & Engineering Project Leader

Date: Apr 28, 2021

Location: Etobicoke, ON, CA, M9W 6Y3

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 managing and ensuring the compliance of projects related to Process Validation, Cleaning Validation and Equipment and Facility Qualifications. Accountable for communicating status of these validation projects to the management group.  Responsible for the review and approval of proposed validation documentation and strategies which ensure the validation program remains compliant with the TPD, FDA, EU, Apotex SOPs and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of the Validation requirements for various departments such as R&D Formulation Development, Engineering, Technical Operations, Production, Regulatory Affairs and other subsidiary groups within Quality.

Job Responsibilities

 

  • Reviews validation strategies and associated documentation against requirements of the VMP to ensure that compliance and business needs are met
  • Acts as QA reviewer or approver on Process Validation (PV) protocols, reports, Change Controls Records (CCR),  Commissioning documents, Preventative Maintenance (PM) & Calibration orders, Building Systems investigations, Cleaning Validation (CV) protocols and other documents
  • Performs technical assessments to determine impact of changes to validation status using the appropriate CCR procedures and acts as QA approver as required
  • Acts as QA SME for review/approval of proposed remedial and corrective actions related to deviation investigation and other excursions related to out of trend/specification of validation/qualification data, as required. Ensures that proposed CAPA are assessed for validation impact
  • Reviews cleaning failures and ensures deviation investigations are initiated following existing procedure, as required
  • Provides training on PV, EFQ, CV and CSV topics to the Quality Validation & Engineering team and internal customers, as required

Job Requirements

 

  • University degree in Science or Engineering
  • Over 5 years of pharmaceutical, food or cosmetics manufacturing experience with a minimum of 4 years within a technical Validation role
  • Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using statistical tools for evaluation of process capability and control
  • Experience in a solid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to Validation would be an asset
  • Proven organizational, time management, and project management skills
  • Excellent oral and written communications

COVID-19 Update

 

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

 

 

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.