Associate I, Quality Control Lab - Analytical Science & Technology (AS&T)

Alcon • Full-time • Singapore - MTO Aseptics, Singapore • 3d ago

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Associate I, Quality Control Lab – AS&T you are responsible in planning and establishing robust and effective laboratory systems, state of art equipment/technologies to support the product/method lifecycles. Maintaining laboratory compliance standards to be inspection ready. Drive and promote a continuous improvement culture to improve the quality and efficiency of QC workflow and processes in our Tuas facilities. In this role, a typical day will include:

Responsibilities

Subject matter expert (SME) for the lifecycle of analytical/microbiological test methods:
- Manage and maintain the lifecycle of analytical and/or microbiological test methods, including method validation, method verification, method transfer, method troubleshooting & improvement, method performance periodic review.
- Develop/draft and execute protocols for method validation, verification, transfer and improvement within project timeline and budget. Create or update test procedure and data sheet. Coordinate and complete change requests.
- Perform data trending and analysis and monitor test method performance. Analyze data to identify unfavorable trends, investigate underlying causes, address issues with relevant stakeholders, implement effective actions and to drive improvement on the method robustness.
- Lead, manage and execute projects of small to medium scale and complexity.
- Review and assess external standard and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance.
- Develop Annual Product Quality Review (APQR) sub-reports and ensure timely submission of sub-reports without overdue.
- Site point of contact for global communities/initiatives pertaining to test method lifecycle.
- Provide guidance, coaching and training to the team as required. Conduct training for new or changed test procedures or techniques.

General responsibilities:
- Meet quality objectives set by management & comply to Alcon, QMS and Safety requirements.
- Timely report non-conformance, out-of-specification, out-of-trend, out-of-expectation events. Lead or assist in root cause analyses for product defects and quality lapses, and take effective actions to prevent recurrence.
- Timely completion of all compliance activities without overdue, including but not limited to non-conformance investigation, OOS, CAPA, effectiveness check, change request, training, periodic review.
- Review/approve records/documents. Maintain integrity, accuracy and completeness of data and records.
- Compile data to support business and performance metrics reporting.
- Support and back up other AS&T projects/activities, including laboratory testing asset lifecycle, stability program, Laboratory Information Management System (LIMS)
Improve quality and efficiency of QC workflows/processes:
- Drive and promote the continuous improvement culture. Challenge current processes, identify improvements and drive the effort to implement lab system/process while maintaining compliance and reducing human Intervention.

What You'll Bring to Alcon

Bachelor Degree in Chemistry, Bioscience or Microbiology Engineering Related Study
Experience with validation, verification, transfer of analytical test methods and/or microbiological test methods.
1-3 years experience in pharmaceutical/medical device industry with GMP knowledge.
Good understanding of the industrial practices and regulatory requirements related to laboratory equipment and computerized systems.
Experience of working in/with QC laboratory. Understand QC requirements and laboratory processes/workflow.
Experience in leading or managing project.
Experience with managing stability studies, metrology equipment, data analysis or data analytics is an added advantage.
Certified greenbelt is an added advantage.

Why Join Us:

Opportunity to work with a leading global medical device company.
Collaborate with a diverse and talented team in a supportive work environment.
Competitive compensation package and comprehensive benefits.
Continuous learning and development opportunities.

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Unlock New Opportunities for Your Career

Retrain or upskill for a new career or a promotion in pharmaceutical manufacturing, equipment qualification, validation, CQV, CSV, risk management, GMPs, quality assurance or pharma skills and knowledge.

Take a proper course that comes with weekly coursework, deadlines, workshops, and an end-of-module assignment.

Click here to learn more about courses GetReskilled offers