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- Ensure that all aspects of handling, testing and documentation in QC are in compliance with GMP, Alcon Corporate Standards and any applicable Regulatory/Medical Device Standards that may apply. Ensure that any identified compliance gaps are escalated and appropriate actions to address the gaps are put in place.
- Data Integrity: Ensure that all associates always apply and follow the Data Integrity principles of ALCOA+. Promote awareness of the Data Integrity principles and ensure that all adequate support is provided to implement all Data Integrity initiatives at the site.
- Monitor Product Quality Compliance. Analyze testing results and the frequency and severity of product defects and quality lapses. Conduct root cause analysis for product defects and quality lapses.
- Manage Laboratory Operations. Determine and implement optimal calibration and maintenance standards for laboratory equipment operation. Investigate underlying causes, technical faults and practices that impact laboratory operations and systems functionality. Provide prompt technical support for equipment breakdown troubleshooting and diagnostic recovery. Manage and maintain sufficient lab supplies and ensure no shortage of supplies. Drive sourcing of new/alternative lab supplies for business continuity.
- Plan, initiate and monitor QC training for QC associates in regular intervals. Responsible for QC training program and implementation.
- Responsible in Stability Management Program. Review and approve stability records.
- Optimize quality and efficiency of QC workflows and activities. Oversee the introduction of new workflow improvements to improve efficiency. Establish Good Laboratory Practices policies. Develop strategies and implement initiatives to encourage continuous improvement of QC procedures, activities, and workflow management. Monitor the effectiveness of improvement and changes made. Facilitate the laboratory gap/regulatory assessment.
- Support launches of product in close collaboration with AS&T. Review and approve analytical method validation, instrument qualification and requalification. Ensure all validation work follow Alcon local procedures and quality manual, ISO13485, US FDA, EU MDR and applicable regulatory requirements. Participate in AS&T global community meetings.
- Manage department financial budget and drive productivity and savings in the organization.
- Drive HSE compliance, model behavior and manage associates in a manner, which provides a safe work environment for all associates that meets site HSE requirements.
- Work with cross-functional teams to drive QC operations objectives and quality improvement.
- People development. Supervise / Provide guidance, coaching and required training to the managing team. Work together with supervisor to improve competency of the team. Ensure effective resource planning, participates in the recruitment, training, and assessment of Quality associates. Coach associates in the areas of technical and professional development. Drive a culture of performance and excellence.
- 7 to 10 years in Quality Control, Laboratory testing and Medical Device or Pharmaceutical Manufacturing in a management capacity
- High level of technical knowledge and proficiency in the field of Quality Control and Laboratory Test Operations.
- Experience in managing and driving results with a team
- 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.
Senior Superintendent II, QC Operations - Singapur, Singapore - SG11 CIBA VISION Asian Mfg & Log Pte Ltd Company
Description
QC Superintendent
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 a QC Superintendent you are tasked to be responsible in overseeing the Quality Control (QC) program. Develop, implement, and maintain robust QC quality management system in compliant with Alcon quality policy and GxP requirements at Tuas . In this role, a typical day will include:
Responsibilities
What You'll Bring to Alcon
Why Join Us: