Investigator, Deviations

Sun Pharmaceutical Industries Ltd•Brampton, ON

5d•CA$73,500 - CA$92,000•Hybrid

About The Position

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients. As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being. Reaching People. Touching Lives. The main responsibility for this position is to provide compliance support to meet Sun and Regulatory requirements and ensure that all activities related to investigations and complaints are completed thoroughly and in a timely manner.

Requirements

B.Sc. degree in a Chemistry/Chemical Engineering stream or related STEM discipline.
Three (3) years of experience conducting investigations and writing Deviation Reports, Complaints, CAPAs, and Change Control in a Pharmaceutical or GMP industry.
Detailed knowledge of cGMP, GLP, FDA and Health Canada guidance and Regulations
Strong research and problem-solving skills, with the ability to effectively perform analysis
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.
Excellent technical report writing skills.
Ability to work in a fast paced environment and prioritize workload accordingly in conjunction with the Production Management
Proficiency with applicable software (TrackWise, MES Document Management System, and Microsoft Office)

Nice To Haves

Knowledge of Manufacturing and packaging processes is an asset

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.
Leads and writes Deviations/Non-Conformances investigation reports
Facilitate meetings with multiple Subject Matter Experts (SME’s) as required.
Perform thorough impact analysis in collaboration with all SMEs including Vendors.
Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager
Works closely with Production Managers and Release Teams to ensure investigations are closed within timely manner.
Supports the CAPA and Customer Complaints programs as requested by Manager.
Identifies and trends recurring Deviations /Non-Conformances and ensures appropriate actions are taken such as Management and Regulatory Notifications
Creates training related to CAPA, Root Cause Analysis and production investigations to Sun employees’ personnel as required.
Develops or assists with Change Controls and SOP’s as required.
Participates in the internal audit program.
Other duties as assigned.
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