Associate, Quality Assurance Packaging & Labeling

Job purpose

The main responsibility of this position is to provide an oversight of the compliance associated with packaging materials and labelling management program. Associate, QA (Packaging and Labelling) will be providing expertise with respect to the packaging design, quality of packaging materials, review and approval of the associated changes. This role is required to ensure compliance with the site procedures as well as Health Canada and FDA regulations.  

Duties and responsibilities

•    Ensure compliance of all process’ stages with respect to packaging materials and labels management, from product development in R&D to commercialization of finished products and throughout the products life cycle.
•    Manage and control the packaging materials Supplier Certification Program.  
•    Lead statistical analysis of supplier performance and conduction an annual review of the data collected; conduct an annual supplier assessment.
•    Provide QA review and approval of change controls for the qualification of new/alternative suppliers of packaging materials.
•    Perform audits of packaging material manufacturer’s sites, review/approve audit reports performed by a third party; execute site internal inspections of the areas associated with packaging materials storage and distribution. 
•    Define critical parameters for each packaging material in order to determine the actions required in the event of a change in these parameters at the suppliers.
•    Define user requirements and adapt the materials to their purpose in conjunction with the packaging engineer, line managers, and the purchasing department.
•    Review and approve manufacturer documents for commercial products.
•    Review and approve Packaging Work Orders and Packaging Materials Specifications.
•    Define, update, approve and control the status of packaging/auxiliary material specifications used for testing and releasing materials.
•    Open and lead change processes related to changes in new packaging materials.
•    Design and manage sampling plan and testing program as per packaging specification requirements.
•    Streamline and improve work processes (introduction of new methods for sampling and testing of packaging materials).
•    Receive alerts about deviations/non-conformances to specifications, investigate and handle the issue, assess associated risks.
•    Handle Warehouse incident reports related to packaging materials.
•    Manage deviations investigations associated with packaging components or labelling failures received from: sampling, laboratories, warehouse, production/ packaging departments and customer complaints.
•    Ensure management and tracking of printed release materials.
•    Lead approval and tracking with suppliers on version updates and new printed packaging materials.
•    Ensure establishment of the appropriate label’s storage and stock control program.
•    Liaise with Taro USA and India Corporate experts on artwork related issues.
•    Manage Product Packaging Safety Compliance Program.
•    Lead all the projects associated with the new Compendia requirements for packaging components and labels and ensure assessment and implementation of the new regulations.
•    Lead implementation of the global documents associated with packaging materials and labelling requirements.  
•    Author and/or review Standard Operating Procedures associated with label controls and packaging materials management.
•    Take an active part in all initiatives associated with design, implementation or change of the electronic solutions associated with labelling and packaging materials.
•    Other duties as required.
Additional responsibility (Only applicable to customer facing roles)

•    Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

•    Bachelor’s Degree in science-related discipline.
•    Previous experience in project management is preferred.
•    Previous sampling and inspecting experience in the pharmaceutical industry, is an asset.
•    Previous experience in the pharmaceutical industry in Quality Assurance or Quality Control.
•    5-10 years’ experience in pharmaceutical environment with direct experience in packaging components
•    Knowledge of/previous exposure and application of Canadian and FDA GMPs.
•    Previous experience with pharmaceutical electronic compliance solutions such as Track Wise, SAP, LIMS etc.
•    Strong user knowledge of Excel, PowerPoint, Word etc. 
•    Strong written and verbal communication skills to communicate effectively with key areas/departments.
•    Strong interpersonal skills to facilitate effective interaction with co-workers and other departments (Warehouse/QA, Materials Management, Art Dept., etc.).
•    Ability to multi-task with strong organizational skills to organize daily events to meet department requirements and company business needs.
•    Ability to work in a fast-paced environment and prioritize workload.
•    Training in WHMIS.
•    Strong computer skills is an asset.
•    Routine problem solving (i.e. establishing multiple sampling and inspection priorities on a daily basis); investigate concerns determining root cause and recommending corrective action to move the situation forward (i.e. damaged goods, multiple manufacturer’s lots received under one receiving lot number); make recommendations for CAPA and/or other process challenges, based on experience (as SME).

Working conditions
Generally, office work, but employee will be required to adhere to safety standards when in Production or Warehouse environment.

Physical requirements
Office based.

Direct reports
NA