Job Type : Full Time
Job Type : Posting Date :
Location : Brampton, Ontario
Taro is a multinational; science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
Our Brampton location is presently looking for a Deviations Investigator to join our Quality Assurance Department.
The main responsibility for this position is to provide compliance support to meet Taro 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) and other Taro Personnel.
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 Taro employees personnel.
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.
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 Taro Canada
If you are interested in this opportunity, please submit your resume to hr taro.ca referencing Deviations Investigator, QA in the subject line.
We thank all applicants, but only those selected for further consideration will be contacted. No phone calls please.