Auditor Documentation Specialist

1 month ago

Montreal, Quebec, Canada Ropack Pharma Solutions Full time

About Ropack Pharma Solutions

Ropack Pharma Solutions is a reputable company that is a leading provider of key contract services, including primary packaging and oral solid form manufacturing for the pharmaceutical, nutraceutical, food, cosmetic, and clinical trial packaging and distribution industries in Canada.

We are seeking a motivated and proactive individual to join our team as a Documentation Auditor.

Key Responsibilities

  • Open production files
  • Generate production labels
  • Support production by providing necessary documents
  • Ensure compliance with established production start dates according to the production planning schedule
  • Review and release executed production files
  • Issue conformity certificates following production file review
  • Prepare sample shipments of bulk, semi-finished, and finished products
  • Investigate reconciliation issues
  • Review production files in the production room
  • Collaborate closely with the compliance team, production, warehouse, billing, and customer service teams to ensure timely delivery and service level agreements
  • Track files pending non-conformity, validation reports, or any other reason preventing product release
  • Respond to customer inquiries
  • Participate in continuous improvement processes to maintain high quality standards while improving process efficiency and organizational performance
  • Manage narcotics (receipt, shipment, clerical tasks)
  • Perform any other tasks as needed by the company

Requirements

  • Bachelor's degree in science or related field
  • 2-5 years of relevant experience in controlled documentation and narcotics management
  • Familiarity with current BPFs. Demonstrate flexibility

Skills

  • Windows environment mastery
  • Bilingualism
  • Proactive approach
  • Sense of urgency
  • Ability to synthesize
  • Ability to interact with various stakeholders/departments

Assets

  • Familiarity with HACCP standards

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