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Project Leader, Quality, Validation & Engineering

APOTEX

This is a Contract position in Etobicoke, ON posted August 3, 2022.

 

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 and adheres to the Validation Master Plans (VMP) for compliance with regulatory requirements
  • Reviews validation strategies and associated documentation against requirements of the VMP to ensure that compliance and business needs are met
  • Acts as QA reviewer/approver on:
    • Process Validation (PV) protocols, reports, Change Controls Records (CCR) and other documents
    • Commissioning documents (e.g. SAT, FAT, qualification protocols), Engineering CCRs, Preventative Maintenance (PM) & Calibration orders, Building Systems investigations and other documents
    • Cleaning Validation (CV) protocols, reports and other documents
    • Technical Operations protocols and reports and other documents
    • Computer Systems Validation (CSV) protocols, reports and CCRs
  • Works with PV, Equipment & Facility Qualification (EFQ), CV, CSV and Technical Operations to provide support and guidance to customers (e.g. Production, Facilities, Engineering, Formulation Development) in problem solving and troubleshooting of validation issues and suggests CAPAs as required
  • 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
  • Acts as a member of teams/committees such as New Product Launch, Change Control Board to provide guidance related to validation regulations/guidelines
  • Reviews cleaning failures and ensures deviation investigations are initiated following existing procedure, as required
  • Participates in periodic review of PM and Calibration trends
  • Via review of PV protocols/reports, ensures that manufacturing/packaging processes are maintained in a validated state of control; provides notification of discrepancies/concerns to department Manager
  • Reviews Master Manufacturing and Packaging Records CCRs for appropriate validated parameters and supporting documentation. Reviews/approves impact of changes to validation status, according to the applicable CCR procedures
  • Provides training on PV, EFQ, CV and CSV topics to the Quality Validation & Engineering team and internal customers, as required
  • Supports QA and Validation during inspections by regulatory agencies
  • Reviews and provides feedback for SODs pertaining to validation activities
  • Assists in coordinating the training of new employees
  • Immediately raises concerns to the Manager
  • Assumes certain responsibilities of the Manager in their absence
  • Ensures that all work is performed in full compliance with Good Manufacturing Practices and Standard Operating Documents/procedures
  • Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities
  • Works as a member of a team to achieve all outcomes
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance and Passion

All other relevant duties as assigned

Job Requirements

  • Education
    • Bachelor of Science/ Engineering or equivalent.
  • Knowledge, Skills and Abilities
    • Experience in a solid dosage manufacturing environment, with a strong understanding of TPD, FDA, EU and other applicable regulatory guidelines related to Validation.
    • Demonstrated high level of knowledge, skill, or expertise in validation concepts, with experience using statistical tools for evaluation of process capability and control.
    • Proven organizational, time management, and project management skills.
    • Knowledgeable user of SAP and TrackWise systems.
    • Ability to analyze systems and processes and recommend process improvement.
    • Excellent problem solving and troubleshooting abilities.
    • Excellent oral and written communications.
    • Strong interpersonal skills.
    • Demonstrated ability to work effectively as a team member with employees at all levels of the organization.
    • Ability to work independently with minimal supervision.
    • Strong customer service orientation.
    • Working knowledge in the use of Microsoft office tools or similar software.
  • Experience

5+ years of pharmaceutical manufacturing experience with a minimum of 4 years within a technical Validation role.

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.