Quality Assurance – Investigations
Position: Senior Executive / Assistant Manager
Key Responsibilities:
. Initiates investigations as needed, collects data, determines the source of the problem using tools such as the Ishikawa diagram, the “5 whys” and/or the DMAIC approach, performs the risk assessment, determines the CAPAs, concludes the investigation and determines the disposition of the impacted lots.
. Plans and leads meetings with various stakeholders when required.
. Maintains up-to-date monitoring of investigations and CAPAs.
. Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe.
. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners.
. Develops and maintains key performance indicators (KPIs) for the investigations and CAPA sector to monitor their effectiveness and compliance.
. Ensures compliance across multiple stages, including compliance with the various stages of investigations and CAPAs, in accordance with applicable SOPs.
. Provides support for internal and regulatory inspections, as needed.
. Collaborates closely with other departments to understand, expedite, and quickly finalize investigations.
. Reviews proofs for drug submissions (Drug Identification Number – DIN), natural health product launches (Natural Product Number – NPN) intended for the Canadian market as well as for commercial products in accordance with regulatory requirements.
. Initiates and evaluates change controls as needed.
. Advises stakeholders on requirements related to printed materials and actively participates in resolving issues related to printed product materials.
. Collaborates closely with the Regulatory Affairs department.
. Promotes Good Manufacturing Practices (GMP).