QUALIFICATIONS

• Sound knowledge and application of Health Canada and FDA regulations.
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills.
• Strong organizational skills and ability to multi-task; detail oriented.
• Recommends changes and requests investigations where required
• Any deviations to procedures or systems are brought to the QA Leadership attention with logic, data and corrective measures
• Implement short range strategies and objectives towards enhancing the quality standards of the department and facility
• Requires Bachelor’s Degree in Science, or related discipline
• A minimum 5 years of experience in a Quality role within the pharmaceutical industry
• Experience with investigations

PHYSICAL REQUIREMENTS

Office based.

JOB PURPOSE

The Associate, QA (Complaints and Investigations) will be accountable for managing/owning investigations records through initiation, the investigations process including root cause analysis to record closure. This position includes interaction with various level of SME’s from multiple departments, QA and external customers.

DUTIES AND RESPONSIBILITIES

• Independently uses root cause tools to drive quality product complaints and unplanned deviation investigations to timely closure ensuring investigation timeline is met.
• Perform investigation activities in Track Wise and assign completions dates to SME’s action owners that ensure actions are progressing quickly including creation of CAPA.
• Develop and present critical finding or issues
• Appropriately escalate concerns to QA leadership regarding the progress of an investigation or implementation of appropriate CAPA
• Identify recurring quality investigations and ensure appropriate actions are taken such as Management notification
• Provide support to the CAPA and Out of Specification Investigation programs as requested by Manager
• Ensure that each investigation record is investigated appropriately ensuring all activities related are completed in a timely manner and in compliance with company and regulatory requirements and well written documentation practice
• Manage extension request and CAPA Effectiveness check in Track Wise
• 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