Senior Chemist

Job Requirement

Qualification: Minimum Bachelor Degree in Chemistry/ Polymer Chemistry or Chemistry related field Minimum 8 years working experience in lab and manufacturing environment with 3 years of manager role.

Experience:

• Knowledge in medical devices, validation, audit, quality management system, cGMP, and FDA in a regulated environment.
• Knowledge and experience in medical device regulations, ISO 9001 and ISO 13485 quality management systems, and good manufacturing practices.
• Strong knowledge of laboratory techniques, instrumentation, and safety protocols.
• Excellent organizational, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced and dynamic environment.

Other Personal Capabilities: Time-management, problem solving, action orientated, interpersonal skills, communicate effectively, ability to multitask efficiently, logical and analytical mindset to identify trends.

Job Responsibility

DUTIES AND RESPONSIBILITIES:

Verification of incoming chemicals and latex

1. Create and update inspection plans for incoming raw materials, ensuring they comply with specifications and standards.
2. Collaborate with other departments, including purchasing and QA, to address any issues related to incoming materials.
3. Identify and resolve any deviations from standard operating procedures or issues related to incoming materials.
4. Issue non-conformances to suppliers of raw materials, products and/or services that does not conform to the specifications and standards through QA.

Verification of in process samples and dipping tank control parameter

5. Plan in process sampling schedules with production and manage the collection samples as per schedule for analysis and monitoring.
6. Manage all testing and analysis of semi-finished goods are conducted accurately, in accordance with established procedures and standards defined, before proceeding to the next stage of production.
7. Provide timely feedback to Compounding and/or Production department to take corrective action to avoid potential test failures.

Verification of finished goods

8. Provides Production and/or QA department with accurate analysis of finished products.
9. Ensure that finished products meet quality standards and are compliant with regulatory requirements before being released from Production and/or QA department.
10. Complete verification in a timely manner with accurate laboratory Analysis report.

Laboratory operations and testing process

11. Implement and enforce laboratory policies, procedures, and protocols to ensure optimal laboratory performance.
12. Manage daily operations of the laboratory by coordinating and scheduling laboratory assignments to laboratory personnel.
13. Provide training and guidance to laboratory personnel on inspection procedures and quality standards. Identify the root cause of, strive to resolve poor analysis problems and coach staff for better performance.
14. Oversee and inspect the execution of testing procedures, ensuring adherence to SOPs and applicable standards (e.g., ASTM)
15. Manage laboratory inventory, including ordering and maintaining proper stock levels of reagents, chemicals and equipment.
16. Troubleshoot and resolve any arising issues in laboratory operations, including equipment malfunctions, supply shortages, and personnel concerns.
17. Manage and ensure laboratory environment (e.g. humidity, temperature) is kept in compliance with good laboratory practice standards.
18. Implement and oversee quality assurance and quality control programs to ensure the highest level of accuracy and precision in laboratory testing and analysis.

Plant Equipment / Laboratory Instrument Verification/Calibration

19. Ensure the plant equipment /laboratory instrument are verified/ calibrated and maintained according to prescribed intervals to deliver accurate results.
20. Track and manage timely servicing and/or verification/calibration of plant equipment /laboratory instrument by external vendors while ensuring availability (returned from vendor) of the equipment.

Tracking, analysing and reporting trends (Laboratory Information Management System)

21. Analyse test results, document findings and generate reports to support quality related decisions.
22. Maintain accurate records of inspections, testing results and any corrective actions taken.
23. Reviewing completed analytical testing reports. Electronic review, approval and signing and update of raw material/finished product testing trend files.
24. Escalated and alert Production and/or QA department of potential total failure through trends emerging from analysis.

Drive Continuous Improvement

25. Identify areas for improvement to drive towards improvement of efficiency, effectiveness and cost.
26. Drive implementation of improvement project towards completion and realisation of benefits expected, through close collaboration with other departments and teams.

Safety, Standards and Compliance

27. Manage, review and control issuance of Standard Operating Procedures (SOP) and Work Instructions (WI) across the entire plant to ensure that the current work practices are effective and accurately reflected as per documented in the documents.
28. Cultivate and enforce safe working practices, ensuring the workforce adheres to safety protocols (e.g., usage of PPE) and compliance with safety, health and environmental standards, while driving initiatives toward zero lost-time injuries.
29. Drive compliance of manufacturing operations towards management systems such as Quality Management System (QMS) ISO 13485 & ISO9001, Occupational Health & Safety Management System (OH & SMS) ISO45001 and Environmental Policy and Environmental Management Systems (EMS) ISO14001

Develop Human Capital

30. Mentor inexperienced subordinates to develop skills and provide technical leadership (formal or informal) through on the job experience as well as comprehensive understanding of the laboratory and operational requirements.
31. Monitor team performance against target Key Performance Indicators (KPIs), goals, career development and collaborate with HR to strengthen the subordinates’ competencies and talent supply.
32. Monitor workforce compliance in accordance to prevailing policies and guidelines, such as work hours, overtime, working conditions, fair treatment, wellbeing, etc.

Others

33. Any other task and/or assigned duties as required by the management.