Associate, Quality Assurance; Investigations

Driven by abold pursuit of science and fueled byan 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, weimprove access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives.

Associate, Quality Assurance (Investigations) is responsible for ensuring products are manufactured, inspected, tested and packaged according to GMP and Company requirements. This is done on a day-by-day basis by the ensuring deviations and non-conformance investigations are managed in compliance with Sun Pharma Global Quality Standards, GSOPs, SOPs and Regulatory requirements.

In addition, Associate, Quality (Investigations) is accountable to ensure effective guidance for the QC Subject Matter Experts on Out-Of-Specification, Out-Of-Trend and Lab Event records and identification of the root cause, assessment of the associated risks and establishment of the effective CAPAs.

• Support investigations associated with manufacturing/packaging, and/or Quality Control functionality such as Out
  - Of
  -Specification, Out-Of-Trend, Lab Events and Deviations
• Ensure identification of the root cause of the issue and execute risk assessments based on the findings of the investigation
• Ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed in a timely manner and in compliance with the company and regulatory requirements
• Obtain and keep current Lead Investigator and Approver certification status as per the Certification Program requirements
• Ensure appointment of the Subject Matter Experts (SMEs) from the QC and Production and their participation in the investigation’s execution and Board discussions
• Support all activities associated with Investigator and Approver Certification Program
• Manage Track Wise access and system training of the site personnel involved in the investigations based on their training and certification status, perform the role of the Track Wise Superuser at the site
• Ensure assessment of the CAPAs effectiveness and timely execution of all the associated actions
• Identify relevant regulatory requirements for non-conformance investigations and ensure their implementation in the facility
• Deliver training related to Root Cause Analysis, Investigations and CAPAs to the site personnel
• Work with other departments to proactively build quality into the processes and systems
• Develops or assists with Change Controls and SOP's as required
• Participate in Internal, Customer and Regulatory Audits
• 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

• Bachelor's Degree in Science, or related discipline
• Minimum 3 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical industry preferably in handling non-conformance investigations.
• Good working knowledge of pharmaceutical Quality Systems.
• Experience in coordinating team activities
• Experience in dealing directly with Regulatory Agency officials (Health Canada and FDA,)
• Sound knowledge and application of Health Canada and FDA regulations
• Knowledge of pharmaceutical standards, transfer guidelines, validation requirements
• Capable of leading by influence in matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS), Electronic Documentation Management System (EDMS), and SAP is an asset

• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail

• Office based role

This posting is for an existing…