Quality Manager/Validation Specialist

Full Time
Professional
Kelowna, BC, CA

Imagine you’ve previously verified a specific set of risk driven inspections and tests for a stock sub-assembly containing parts from several different suppliers.  A change in engineering specification, triggered by new customer needs, elevates the risk of contamination to the end user’s production processes for the previously built sub-assemblies.  The sub-assemblies can only be remediated at time of installation on site rather than at the original manufacturing location subject to customer acceptance of the remediation steps.  You’re relied upon to guide several people through a process of gaining documented customer acceptance.  This is one example of a situation in the life of our Quality Engineer.  Interested?  We are looking for a Quality Engineer to oversee the design, manufacturing, inspection, qualification and validation of equipment used for biopharmaceutical product manufacturing.

About Vitalis Extraction Technology

Vitalis Extraction Technology engineers, manufactures, and markets supercritical fluid extraction systems used to separate concentrates from organic materials for a wide range of industries including analytics, vitamins/supplements, vanilla, caffeine, ingredient development, GHG protocol, food waste, life sciences, biopharmaceuticals, cannabis, hemp, pharmaceuticals, food and beverage, fragrances and essential oils. While our operations have grown to span five continents – and counting – we are proudly rooted in beautiful Kelowna, BC Canada.

At Vitalis, we treat our employees the way we treat our customers. We embrace diversity and equal opportunity and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

We are looking for professionals that want to join our high-paced and innovative environment that encourages a culture of curiosity, professionalism, resourcefulness, and gratitude.

Responsibilities

  • Lead and support the management team to bridge process gaps and achieve ISO 9001:2015 certification.
  • Perform regular quality system maintenance, auditing and cross functional training activities
  • Review, approve, perform validation and inspection activities related to: URS, DQ, FDS, FAT/SAT documents/commissioning documents, IQ, OQ, PQ, Validation plan, Risk assessment, and validation summary reports.
  • Assist the customer and Implementation Team with the qualification and validation of new and existing equipment with the focus on GMP compliance.
  • Collaborate with Purchasing for vendor Quality/GMP prequalification
  • Compile and validate turnover documentation
  • Support planning and performing quality system & GMP internal audits
  • Perform QA & QC functions in consultation with other departments (engineering, production, purchasing, etc.)
  • Review and report in a timely manner on machine Factory Acceptance Test data/documentation
  • Validate sensor, gauge and raw material traceability and documentation.
  • Review and approve deviation/non-conformance/change control/CAPA (events) reports and records from validation/qualification/internal manufacturing perspective.
  • Review software validation tools (batch data), QC analytical instruments, spreadsheets, and other electronic systems or measurement devices.
  • Support the setup and maintenance of other validation programs and activities including cleaning, transportation and computer system validation
  • Communicate, follow-up and document engineering specified corrective actions
  • Support Engineering with the product preventive maintenance and calibration schedules
  • Aid in clarifying service and product quality acceptance criteria.
  • Learn, communicate and implement new design and product licence QA/QC requirements
  • Ensures and enforces Good Documentation Practices on all applicable documents relating to GMPs
  • Maintain a strong working knowledge of Vitalis products and peripherals

Required Skills & Qualifications

  • Technology Diploma or Bachelor’s Degree in Quality, Chemistry, Bio-Chemistry, Pharmacology, Pharmacy, Microbiology, Mechanical, Chemical, Manufacturing,  Engineering or Pharmaceutical Engineering

  • Two-five (2-5) years relevant work experience in pharmaceutical equipment manufacturing industry

  • Within the context of design, manufacturing, inspection, qualification and validation of equipment purposed for biopharmaceutical product manufacturing, thorough understanding and experience in the practical application of some or all the following:

    • ISO 9001:2015 Quality Management Systems – Requirements

    • Eudralex – Volume 4 – Good Manufacturing Practice (GMP).  In particular:

      • Part 1 Chapter 1 Pharmaceutical Quality System
      • Part 3 Q9 Quality Risk Management
      • Annex 15 Qualification and Validation
    • ASME BPE Bioprocessing Equipment

    • ISPE GAMP 5 – A risk-based approach to compliant GxP Computerized Systems

  • Familiarity with stainless steel fabrication and machining practices

  • Experience implementing and maintaining an ISO 9001:2015 quality management system

  • Familiarity with sub-contract/supplier quality surveillance

  • Proven knowledge and experience in applying the risk based approach throughout the manufacturing process

  • Excellent English skills both written and verbal

  • Eligible to work in Canada

  • Willingness to travel within USA and Canada

Please respond with a cover letter and resume. Successful candidates will be contacted for interviews. We look forward to reviewing your application!