Easter Seals Jobs

Job Title: Specialist Quality Services (Product Complaints), Kuala Lumpur Hub, Business Operations

About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Specialist Quality Services (Product Complaints), Kuala Lumpur Hub, Business Operations, you’ll will act as partners to M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Main responsibilities

• Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.

• Evaluate complaints for severity and risk, ensuring timely review and processing.

• Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites.

• Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations.

• Focus on operational tasks within the compliant handling process.

• Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections.

• Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.

• Identify and implement continuous improvement opportunities in complaint management.

• Provide regulatory interpretation and guidance to internal teams and corporate partners.

• Manage and oversee the training within the team.

• Perform quality checks on activities, prepare reports, and maintain inspection readiness.

About you

Experience:

• 3+ years of related experience in the pharmaceutical industry.

• Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.

• Should be knowledgeable in Quality functions of pharmaceutical industry.

• Experience of working on manufacturing sites is an added advantage.

• Proficient in problem-solving, attention to detail, and good organizational skills.

• Work in a team-oriented, flexible, and proactive manner.

• Analytical skills and ability to multitask in a stressful environment.

• Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including health insurance, out-patient benefits along with a range of family friendly policies such as maternity, paternity, and solo parent leaves to name a few.