Specialist, Quality Assurance in Brampton

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.

Job purpose: Specialist, Quality (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 ensuring deviations investigations are managed in compliance with Sun Pharma Global Quality Standards, GSOPs, SOPs and Regulatory requirements through the identification of the root cause, assessment of the associated risks and establishment of effective CAPAs.

Duties and responsibilities:

• Ensure identification of the root cause of the issue and execute risk assessments based on the findings of the investigation.
• Ensure 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 maintain current Lead Investigator and Approver certification status as per the Certification Program requirements.
• Ensure appointment of the Subject Matter Experts (SMEs) from relevant areas and their participation in the investigation’s execution and Board discussions.
• Support all activities associated with Investigator and Approver Certification Program.
• Manage TrackWise access and system training of the site personnel involved in the investigations based on their training and certification status.
• 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.
• Work with other departments to proactively build quality into the processes and systems.
• Develop or assist with Change Controls and SOP's as required.
• Participate in Internal, Customer and Regulatory Audits.
• Other duties as assigned.

Qualifications:

• Bachelor's Degree in Science, or related discipline.
• Minimum 1 Year 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).
• Knowledge of pharmaceutical standards, transfer guidelines, validation requirements.
• 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.

Working conditions:

• 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.

Physical requirements:

• Office based role.
• Regular hours are 8:00am to 4:30pm with extended hours as required to resolve urgent issues.

This posting is for an existing vacancy.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.