Quality Compliance Associate

2 days ago

Winnipeg Manitoba RJW Canada IVC Vita Health Full time $54,000 - $78,000 per year

Position: Quality Compliance Associate    

IVC Vita Health is a leading manufacturer and distributor of quality Natural Health Products (NHP) and Over-the-Counter (OTC) pharmaceuticals. With over 70 years of experience in pharmaceuticals, we are seeking dynamic individuals to join our growing team.

Expectations:

Under the direction of the Material Specification Supervisor, the Quality Compliance Associate is responsible for creating and maintaining packaging (Artwork) specifications, including oversight of quality standards. Responsible for review and approval of Blister Print Mat mock-up and final Print Mat from Packaging Department against approved Blister Standards.

The Quality Compliance Associate will also be responsible for conducting activities that ensure Vita Health's product specifications are in compliance with GMP Regulations, regulatory filings, and applicable standard by collecting information in support of vendor qualification activities.

Specific Duties:

  • Creation and maintenance of raw material, bulk, finished product and printed and non-printed packaging specifications
  • Maintains packaging (box, label, insert) specifications, including oversite of in-house Quality Standards and of Customer Supplied Art.  Collaborates with cross functional departments to ensure changes are made in continuity with product formulation changes.
  • Responsible for the creation and maintenance of specifications and documents to assure compliance to meet internal customer requirements, manufacturing capability, applicable compendial monographs or market regulations.  Collaborates with cross-functional departments to understand the requirements to be included in new and revised product Specification documents
  • Responsible for review of Blister Print Mat mock-up and Final Print Mat from Packaging Department, against approved Blister Standards and complete associated specification sheet.
  • Provides Quality oversight over the material qualification process, reviews vendor documentation, and drafts specifications.
  • Initiates change requests related to specifications to ensure specification completeness and integrity including claims to support label requirements.
  • Other duties may be assigned as required

 Qualifications and experience required:

  • 1-3 years of experience within the pharmaceutical industry specifically in Quality Compliance, Quality Assurance, or in the Quality Control Laboratory is an asset.
  • Strong working knowledge of drug and NHP compendial applications as it relates to specifications
  • Experience working directly with regulatory agencies.
  • Strong written and verbal communication skills; ability to collaborate with internal/external departments/groups/resources.
  • Proven problem solving ability with good judgement and decision making skills, management of multiple priorities, able to meet strict and established timelines.
  • Working knowledge in computer applications (Microsoft word, excel, PowerPoint).
  • Strong organizational skills, ability to work in a team environment, as well as independently.
  • Ability to prioritize workload, multi-task and maintain compliance
  • University level degree (B.Sc.) or College Diploma in Science (Chemistry, Biochemistry, or Microbiology preferred).

If you would like to become a team member in our growing organization, please apply today

We thank all applicants for their interest, but only those selected for an interview will be contacted.

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