Quality Compliance Associate

2 weeks ago

Winnipeg, Canada Vita Health Products Inc. Full time

**_Position: Quality Compliance Associate _**

Vita Health Products Inc. 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:_**

Reporting to the Material Specifications Supervisor, you are responsible for the packaging (Artwork) specifications, including oversight of quality standards. This position will work with our Regulatory Affairs and Operations Departments to ensure that packaging specification changes are made in continuity with product formulation changes, and collaborate with Operations and external packaging experts to ensure the packaging specifications meet or exceed industry standard. Additionally, this role will be involved in collecting information in support of vendor qualification activities.

The Quality Compliance Associate will also be responsible for conducting activities that ensure Vita Health’s product specifications are in compliance with GMP Regulations, as well as Regulatory Agency filings, and applicable standards. This individual has an understanding of GMP requirements, especially as it relates to the analytical testing of Over-the-Counter drugs (OTC) and Natural Health Products (NHP) per GMP requirements (e.g. Health Canada, FDA, etc.), and the use of different pharmacopeia (e.g. USP) to determine testing requirements.

**_ Specific Duties: _**
- Responsible for the creation and maintenance of raw material, bulk, finished product and printed and non-printed packaging specifications
- Determines certificate of analysis requirements needed to ensure materials meet physical, chemical, and contaminant requirements
- Works in close collaboration with key stakeholders to conduct material assessments as part of the specification development process
- Provides Quality oversight over the material qualification process, reviews vendor documentation, and drafts specifications
- Ensures specifications are current with all applicable regulations and pharmacopoeias
- Evaluates proposed changes in CCRs and assesses potential impact to specifications
- Supports regulatory filings in relation to specification creation
- Updates SOPs and associated annexes as needed.
- Responsible to 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.
- Initiates change requests related to specifications to ensure specification completeness and integrity including claims to support label requirements.
- Provides technical assistance on issues related to specifications
- Ensures generated specifications are maintained, controlled, updated and communicated to all appropriate levels within VHP.
- Works with associated departments to determine the impact of Product Specification changes and conducts Quality Risk Assessments to ID risks and associated controls.
- Collaborates with appropriate personnel to ensure product specifications are consistent with current regulatory filings and commitments.
- Responsible for tracking milestones and deliverables.
- 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 review of Blister Print Mat mock-up and Final Print Mat from Packaging Department, against approved Label Master and complete associated specification sheet.

**_ _**_Qualifications:_**
- This individual will have University level degree (B.Sc.) or College Diploma in Science (Chemistry, Biochemistry, or Microbiology preferred).
- 1-3 years of experience within the pharmaceutical industry specifically in Quality Compliance, Quality Assurance, or in the Quality Control Laboratory is an asset.
- Excellent written and verbal communication skills; ability to collaborate with internal/external departments/groups/resources.
- Strong organizational skills, ability to work in a team environment, as well as independently.
- Proven problem solving ability with good judgement and decision making skills, management of multiple priorities, able to meet strict and established timelines.
- Ability to prioritize workload, multi-task and maintain compliance
- Attention to details and ability to make decisions based on scientific information.
- Experience working directly with regulatory agencies.
- We thank all applicants for their interest, but only those selected for an interview will be contacted._
- Hourly wage range: $26.50-$28.00/hour_

**Application Deadline: April 12, 2024**:
**Experience**: Required
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