Specialist, Computer System Validation

Date: May 16, 2019

Location: Brantford, ON, CA, N3T 6B8

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

  • Keeps abreast of new regulations/guidelines, emerging regulatory agency and industry trends and keeps Management aware of developments.
  •  Uses sound, technical judgment in making decisions and recommendations and adheres to Company policies, CGMPs and applicable Standard Operating Procedures when performing job responsibilities and assigned tasks.
  •  Effectively manages workload and prioritizes work in line with the overall department and Company objectives and requirements.
  •  Ensures validation activities are performed and completed in a timely manner.
  •  Adheres to schedules, provides timely reports/assessments and ensures appropriate corrective and preventative actions are identified and implemented in a reasonable timeframe.
  •  Ensures information contained in protocols and reports, as well as that provided to support changes and/or qualification/revalidation is clear, concise, accurate, meaningful, scientifically sound, and well documented.
  •  Maintains complete and accurate documentation/records/data (electronic or paper), filed in an organized and easily retrievable manner.
  •  Ensures electronic information systems/databases are both effective and efficient and meet the needs of the department and Company.
  •  Works on continual quality system improvements and efficiencies, developing new or modifications to existing systems, as required.
  •  Provides support, guidance and functional direction in the area of validation and compliance.
  •  Provides routine progress reports and keeps QA management informed of on-going activities.
  •  Works independently or as part of a team, and conducts oneself in a professional manner fostering a positive work environment
  •  Works as a member of a team to achieve all outcomes.
  •  Performs all work in support of our Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values.
  •  Performs all work in accordance with all established regulatory and compliance and safety requirements.

Job Responsibilities

  • Acts as primary QA representative in the company-wide Computerized System Validation Program; as an active standing member of the CSV team, is responsible to fulfil all responsibilities as laid out in company governing policies and procedures.
  • Reviews, recommends and implements changes to validation program, quality systems, and approved procedures as required, ensuring  information, processes, directives, etc. are accurate, practical, and compliant to Regulatory and Industry standards.
  • Spearheads and monitors Computer System Validation projects and provides the necessary guidance to other site personnel to ensure satisfactory and timely completion of all validation activities.
  • Liaises between Quality Assurance and Information Systems, and other departments within Apotex Pharmachem Inc. in relation to the creation, review, and approval of validation deliverables, operating procedures, and quality systems.
  • Co-ordinates, schedules and performs the review and approval of protocols and reports, i.e., DQ, IQ, OQ and PQ, relating to the Qualification of Computerized Systems and other validation/qualification documents as required.
  • Reviews the user, functional, GXP requirements, and ensures successful execution of validation program requirements.
  • Reviews all computer system change controls, deviations, incidents submitted by any department to ensure that the computer system is maintained in an accurate, validated, and compliant state.
  • Participates in vendor audits/assessment; reviews all documentation, including the performance of vendor audits .
  • Authors, reviews and approves procedures and documentation related to computerized systems.
  •  Identifies CSV and other related area training needs, develops modules and delivers training to site personnel on an as-needed basis.
  •  Acts as project lead or provides support/guidance to assigned compliance and/or efficiency projects.
  •  Participates in the internal self-inspection program as an active audit team member.
  •  Participates in Regulatory and Customer Audits as a subject matter expert in the Computerized System Validation program, as required.
  •  Provides backup support in process and cleaning validation programs.
  •  Participates in special projects and performs other tasks as assigned by Supervisor/Management in support of Departmental and Company initiatives.
  • 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;
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
  • All other relevant duties as assigned.

Job Requirements

  • Education
    • Education at the University, or equivalent, level in a related scientific discipline.
  • Knowledge, Skills and Abilities
    • Good working knowledge of applicable regulatory guidelines including FDA (21 CFR Part 11), ICH, and GAMP.
    • Practical background and superior understanding of validation principles and regulatory requirements/guidelines (Canada, USA, GAMP, EU, PIC/S and ICH).
    • Understanding of API / Pharma and/or related industries validation environment.
    • Strong verbal communication and technical writing skills; good negotiation, training and presentation skills would be an asset.
    • Effective project management and leadership skills.
    • Proficiency in computer applications and programs such as Word, Excel, PowerPoint and Project Management related software.
  • Experience
    • Minimum five years’ experience in the Pharmaceutical Industry (or GAMP industry) in the area f Validation, with focus on Computerized Systems.  Knwledge in analytical method validation, equipment qualification, process and cleaning validation is desirable.

 

 

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.

 

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