Quality Assurance Specialist

We are seeking a skilled Quality Assurance Specialist to join our team. As a key member of our quality function, you will be responsible for ensuring the highest standards of quality in our manufacturing processes.

Your primary duties will include monitoring product quality, resolving non-conformances, and maintaining documentation while supporting daily operations and team efficiency.

• Perform visual inspections of white stock and finished products to ensure quality standards are met.
• Review batch production records for compounding, filling, and packaging processes, ensuring all critical steps meet specifications prior to release.
• Assess autoclave reports for compounding and filling operations.
• Conduct annual inspections of retention samples, including identification, segregation, and disposal, and maintain the Retention/Reserve Sample Program.
• Approve Engineering Change Notices (ECNs) and manage updates to the Bill of Materials (BOM).
• Investigate and resolve deviations before batch release.
• Coordinate the review of alarm reports and support impact assessments for critical alarms.
• Support the preparation and administration of Master Documents such as SOPs, Forms, Templates and MBRs.
• Assist in the generation of Annual Product Quality Review (APQR) reports.
• Set up finished goods inspection plans for new products in SAP.
• Track Master Batch Record (MBR) submissions and report weekly performance metrics.
• Conduct aseptic audits of manufacturing processes and facilities.
• Perform in-process checks and critical quality attributes during production shifts (e.g., IPC, IBA, line clearance approval).
• Maintain 5S standards and good housekeeping in the Lot Release area.
• Monitor key performance indicators (KPIs) and escalate issues as necessary.
• Collaborate cross-functionally to support quality operations and continuous improvement.

• Minimum Diploma in Science, Engineering, or equivalent with at least 1-3 years of relevant experience in Quality Assurance within a manufacturing environment.
• Experience in GMP/GDP-regulated industries, such as pharmaceuticals or medical devices.
• Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Experience with cleanroom operations is an advantage.
• Familiarity with MES and SAP systems is also preferred.
• Strong analytical and problem-solving skills, with a keen eye for detail and a commitment to compliance.
• Effective communication and collaboration skills to work cross-functionally and support continuous improvement.

• Career Growth & Development – Gain access to continuous learning opportunities, leadership training, and career advancement programs to support your professional journey.
• Collaborative Culture – Work alongside passionate and diverse teams in a dynamic and inclusive environment that encourages innovation and teamwork.
• Impactful Work – Be part of a purpose-driven company that is improving lives by advancing eye care solutions worldwide.
• Recognition & Rewards – Your contributions are valued and recognized through competitive compensation, performance incentives, and career progression opportunities.
• Global Exposure – Join a world-class organization with opportunities to collaborate across international teams and gain global industry insights.
• Work-Life Balance & Well-Being – Enjoy employee wellness programs, flexible work arrangements, and initiatives that support your well-being.

At our organization, we empower our people to make a difference while growing their careers in an exciting and supportive environment.