Deviations Investigator, Quality Assurance
|Brampton, Ontario - Canada
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WHY IS THIS A GREAT OPPORTUNITY?
Our client in Brampton is currently looking for a Deviations Investigator to join their Quality Assurance Department.
The main responsibility for this position is to provide compliance support to meet the company and Regulatory requirements and ensure that all activities related to investigations and complaints are completed in a timely manner.
- Ensuring 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
- Reviewing and evaluating for completeness and compliance of the investigation reports and resolution plans authored by Subject Matter Experts (SMEs) and other company Personnel
- Maintaining the NCI Database, and using it for tracking and trending activities
- Following up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness
- Supporting the CAPA and Customer Complaints programs as requested by Manager
- Leading and participating directly in the investigation of Deviations/Non-Conformances
- Writing Deviations/Non-Conformances investigation reports
- Identifying recurring Deviations /Non-Conformances and ensuring appropriate actions are taken such as Management and Regulatory Notifications
- Delivering training related to CAPA, Root Cause Analysis and quality investigations to employees’ personnel
- When deemed necessary, performing or facilitating quality investigations
- Developing SOP’s as required
- Participating in the internal audit program
- Other duties as assigned
- 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.
- 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
- 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)
- 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..