Validation Coordinator

Factors Group of Nutritional CompaniesCoquitlam, BC
CA$57,000 - CA$71,500Onsite

About The Position

The Coordinator will perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment. Ensuring compliance with Health Canada/FDA/TGA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures). Responsibilities will include the execution of validation protocols (IQ, OQ, PQ).

Requirements

  • Bachelors Degree in an appropriate science (Chemistry) or Engineering discipline
  • Validation experience or participation in validation work group activities (2+ years)
  • GMP industry experience in pharmaceutical or dietary supplement manufacture of solid dosage forms, in a hands-on technical/analytical role
  • Good analytical laboratory skills
  • Ability to work with computers (specifically MS Office)
  • Knowledgeable about data governance and integrity regulations

Nice To Haves

  • Familiarity with ISPE Baseline Guide 5 (Second Edition)

Responsibilities

  • Maintain and operate equipment in a safe and efficient manner
  • Coordinate with other functional departments to develop and implement validation test plans
  • Prioritize validation activities according to compliance and business needs
  • Coordinate projects and schedules; monitor progress of the validation master plan, procedures and strategies
  • Ensure validation efforts are conducted in an appropriate and timely manner
  • Interact with individuals from different disciplines (Production, Maintenance, Engineering, and Quality) to plan, execute and complete validation activities, including reports and corrective action items to ensure timely completion
  • Oversee validation testing for new products and process improvements
  • Review all key documents developed and executed by applicable personnel
  • Maintain all validation documents
  • Participate in and review all change controls (CC) and evaluate for revalidation activities
  • Adhere to Safety Policies (SPs), Goods Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)

Benefits

  • healthcare
  • health and personal spending accounts
  • wellness days
  • Employee & Family Assistance Program
  • $200.00 safety boot voucher & company provided PPE
  • $300.00 per year to spend on company products
  • Employee discount pricing
  • Employee appreciation events & rewards
  • Free onsite parking
  • Employee wellness sessions
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