Quality Operations Specialist

3 days ago

Singapore beBeeQuality Full time $360,000 - $420,000

Job Title: Safety and Compliance Specialist

Job Summary: We are seeking a highly motivated Safety and Compliance Specialist to join our team. The successful candidate will be responsible for monitoring product quality, resolving non-conformances, and maintaining documentation while supporting daily operations and team efficiency.

Responsibilities: As a Safety and Compliance Specialist, you will perform visual inspections of white stock and finished products to ensure quality standards are met. You will also review batch production records for compounding, filling, and packaging processes, ensuring all critical steps meet specifications prior to release. Additionally, you will 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. You will 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. Furthermore, you will assist in the preparation and administration of Master Documents such as SOPs, Forms, Templates and MBRs, generate Annual Product Quality Review (APQR) reports, set up finished goods inspection plans for new products in SAP, track Master Batch Record (MBR) submissions, report weekly performance metrics, conduct aseptic audits of manufacturing processes and facilities, perform in-process checks and critical quality attributes during production shifts, maintain 5S standards and good housekeeping in the Lot Release area, monitor key performance indicators (KPIs), and escalate issues as necessary.

Requirements: To be successful in this role, you will require a minimum Diploma in Science, Engineering, or equivalent with at least 1-3 years of relevant experience in Quality Assurance within a manufacturing environment. You will need to have experience in GMP/GDP-regulated industries, such as pharmaceuticals or medical devices, a strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Experience with cleanroom operations is an advantage, as is familiarity with MES and SAP systems. You will possess 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 a willingness to work rotational shift schedule across 3x shifts.

Benefits: As a member of our team, you will enjoy career growth and development opportunities, a collaborative culture that fosters innovation and teamwork, impactful work that improves lives by advancing eye care solutions worldwide, recognition and rewards for your contributions, global exposure through international collaborations, and a healthy work-life balance and well-being initiatives.

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