Senior Validation Specialist

November 28 2021
Industries Pharmaceutical, Biotechnology
Categories Engineering, Pharma, Biotech, Sciences, R&D, Chemistry, Quality assurance and control, Validation
Pointe-Claire, QC

Overview

The Sr Validation Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with computer system validation regulatory requirements (e.g. 21 CFR Part 11) is always established and maintained.

The Sr Validation specialist is also responsible for leading qualification activities for production and laboratory equipment (i.e. steam sterilizer, incubator), utilities, processes validation, and cleaning validation at Capcium.

This includes prioritizing, developing validation/qualification strategies, executing, maintaining and coordinating qualification/validation activities, and serving as the liaison between IT department, operational business units and external 3rd party (where applicable). He/she will also review and approve documents (protocols and reports). The mandate also includes validation change management.

Main Responsibilities

  • Validation Strategies
    • Participate in the development of validation / qualification strategies
    • Participate in the drafting / revision of the Validation Master Plan (VMP);
  • Validation Protocols & Activities
    • Write software validation documents (protocols, summaries, traceability matrix, etc) and execute software validation protocols
    • Write and execute qualification protocols and reports (IQ, OQ and PQ when relevant) for equipment, validation protocols for processes and cleaning procedures.
    • Coordinate with other stakeholders to ensure that the related activities are planned and the resources available.
    • Support the engineering team during the selection of new equipment, equipment start-up (FAT and / or SAT);
    • Plan and execute qualification/validation protocols within the expected timelines;
    • Analyze and perform assessments using a risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security. Following the assessment, assign appropriate levels of validation;
  • Deviations & Investigations
    • Write deviations that occur during validation/qualification and recommend corrective actions;
    • Participate in the resolution of gaps, investigations, and deficiencies
  • Documentation
    • Prepare and approve validation documentation packages, including development and execution of documentation for validation and qualification activities to support various validation projects
    • Documents may include: Validation master plan, validation protocols and reports, User Requirements Specifications, Requirements Trace Matrix, Functional and Design Specifications, Protocols (IQ/OQ/PQ), User Acceptance Testing, SOP's, Change Control Documentation, and Risk Assessment reports;
    • Write SOPs and validation protocols in accordance with corporate standards and current GMPs;
    • Maintain validation / qualification documentation and archiving by ensuring efficient document retrieval, when requested;
  • Back-up for this role is the validation manager.

Qualifications

  • Bachelor's degree in Engineering (Chemistry or Mechanics) or Science: Chemistry, Biology, Biochemistry
  • 5-10 years of experience in validation in the pharmaceutical industry
  • Experience in validation of GxP computerized systems
  • Experience in qualification of equipment used in manufacturing and / or packaging of various dosage forms as well as critical systems (HVAC, purified water, compressed air)
  • Experience in validation of cleaning methods and manufacturing processes.
  • Knowledge of use of Kaye Validator
  • Excellent working knowledge of cGMP requirements on validation methods and including ISPE, GAMP and FDA principles, CFR Part 11 (requirements for electronic records and signatures)
  • Capable of developing and writing applicable validation documentation, including but not limited to URS, DOE, FAT, IQ, OQ
  • Experience in project management would be an asset
  • Bilingual: French and English, spoken and written
  • Capable of managing multiple complex projects and working independently
  • Ability to review and approve technical reports effectively
  • Ability to write technical reports clearly and accurately
  • Can work under pressure and adaptation to changes
  • Good sense of communications and emergencies (prioritization)
  • Multifunctional teamwork
  • Proficient in computer tools like Microsoft Office, Outlook, MS Project
  • Office and factory work
  • Travel to production sites may be required
Apply now!

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