Career Connections Canada Inc.
"connecting great people with great companies"
The main responsibility for this position is to provide compliance support to meet company and Regulatory requirements and ensure that all activities related to investigations and complaints are completed in a timely manner.
Principal Duties and Responsibilities
- Ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements.
- Reviews and evaluates for completeness and compliance of the investigation reports and resolution plans authored by Subject Matter Experts (SMEs).
- Maintains the NCI Database, and uses it for tracking and trending activities.
- Follows up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness.
- Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.
- Supports the CAPA and Customer Complaints programs as requested by Manager.
- Lead and participate directly in the investigation of Deviations/Non-Conformances.
- Writes Deviations/Non-Conformances investigation reports.
- Identifies recurring Deviations /Non-Conformances and ensures appropriate actions are taken such as Management and Regulatory Notifications.
- Delivers training related to CAPA, Root Cause Analysis and quality investigations to employees.
- When deemed necessary, performs, or facilitates quality investigations.
- Develops SOP’s as required.
- Participates in the internal audit program.
- Other duties as assigned.
Knowledge, Skills and Abilities
- B.Sc. degree in a Chemistry stream or related discipline.
- Minimum of three (3) years of experience conducting investigations and writing Quality Deviations, Complaints, CAPAs, and Change Control in a pharmaceutical industry.
- Minimum three (3) years of experience in the pharmaceutical industry in Quality Assurance or Quality Control department.
- Previous TrackWise experience is an asset.
- Strong interpersonal skills to facilitate effective interaction with co-workers and other departments.
- Strong written and verbal communication skills are required in order to communicate effectively with key areas/departments.
- Previous experience with sampling and inspecting in the pharmaceutical industry is required.
- Demonstrated technical writing skills.
- Excellent knowledge of cGMP and GMPs requirements for the pharmaceutical industry.
- Ability to work in a fast-paced environment and prioritize workload accordingly in conjunction with the QA Incoming Supervisor.
- 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 (written and verbal) skills.
- Proficiency with applicable software (LIMs, Document Management System, Empower and Microsoft Office).
- Strong understanding in Pharmaceutical Operations.
- Detailed knowledge of cGMP, GLP, FDA and Health Canada guidance and Regulations.
- Knowledge of required instrumentation (IR, NIR & Raman spectrophotometers, HPLC) is an asset.
- Any deviations to procedures, specifications or systems are brought to the Supervisor’s attention with logic, data and possible corrective measures.
- Problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
- Problems associated with dealing with individuals from departments, and working on various functions within and outside of the company.
** Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc.