Coordinator, Quality Assurance

About Sun Pharma

Sun Pharma is a global leader in the pharmaceutical industry, committed to advancing science and delivering high-quality medicines that healthcare professionals and patients trust. Our mission to Reach People and Touch Lives propels us to provide innovative pharmaceuticals, generics, and consumer healthcare products that enhance the well-being of millions. Our diverse portfolio spans multiple therapeutic areas, ensuring accessible, affordable, and effective treatments.

Job Purpose

This role focuses on supporting site-wide Quality Assurance programs, especially in GMP Documentation management and Change Control processes, to comply with SUN Pharma, Canadian, and FDA GMP standards. The position oversees GMP document revision, posting, archival, maintenance, and storage at the QA Documentation Center and third-party storage facilities.

Key Responsibilities

• Coordinate and manage archival, retention, and retrieval of GMP documentation generated at SPCI.
• Provide timely document access support during regulatory inspections and customer audits.
• Handle revision and posting of Quality Control and Master Production documents per assigned Change Control tasks promptly.
• Communicate effectively with stakeholders to ensure Change Control tasks are completed within deadlines.
• Assist QC, QA, and RA departments by updating specifications and test methods essential for regulatory submissions and subsequent implementation.
• Support Production and QA Incoming departments with management of active and archived engineering, packaging specifications, and artwork electronic files.
• Maintain GMP documentation inventory, ensuring timely closure of document requests, transfer to archival storage, and document destruction schedules.
• Serve as backup to Specialist, QA (Documentation) as needed.
• Generate, collect, and analyze data for Quality Systems related to Documentation and Change Controls.
• Prepare reports associated with Documentation and Change Controls Quality Systems.
• Execute assigned tasks to implement new documentation software systems such as EDMS and BRMS.
• Support global SUN projects including GMP documentation and artwork rebranding updates.
• Participate in internal quality audits and self-inspection programs as assigned.
• Complete all required department training within set timelines.
• Identify and suggest improvements related to documentation tasks to enhance efficiency and quality.
• Collaborate with other departments to integrate quality into processes and systems.
• Adhere to GMP compliance and maintain safety consciousness in all duties.
• Undertake other responsibilities as assigned.

Additional Responsibilities (Customer-Facing Roles)

Report any adverse event related to company products received from customers to the pharmacovigilance/drug safety department on the same day or within one business day.

Qualifications

• Bachelor's degree or college diploma in a science-related field.
• Previous pharmaceutical industry experience in Quality or Documentation Coordination is preferred.
• Advanced skills in Microsoft Word and Excel.
• Sound knowledge of Health Canada and FDA regulations.
• Strong verbal and written communication abilities.
• Critical thinking and analytical capabilities.
• Keen attention to detail with the ability to maintain focus while multitasking.
• Competence in prioritizing daily workloads in a fast-paced setting.
• Ability to work independently with minimal supervision.
• Skill in identifying discrepancies, procedural deviations, and task-related issues, bringing them to management attention with supporting data and proposed corrective actions.
• Good interpersonal and teamwork skills.

Working Conditions

• Ability to manage work amid rapidly changing priorities.
• Handling multiple varied responsibilities requiring attention to detail.
• Work environment includes general office and QA Documentation Centre.
• Occasional physical tasks such as lifting and carrying document boxes.

Compensation and Benefits

The anticipated base salary range is 56500 to 71000 CAD annually, potentially varying based on location and experience. The role is eligible for the Annual Performance Bonus Plan. Benefits include medical, dental, vision coverage, life insurance, RRSP savings plan, employee assistance program, vacation, and sick leave. Compensation and benefits are subject to company policies and may be modified as needed.

Additional Information

This job description outlines general duties and qualifications and is not exhaustive. The company reserves the right to modify job duties and assign other responsibilities based on employee experience and organizational needs. Sun Pharma is an equal opportunity employer, providing fair employment without discrimination based on protected characteristics. The employer uses AI screening for applicant evaluation. Additionally, unsolicited resumes from agencies or search firms are not accepted without valid agreements.