Quality Control Lead

Private Advertiser; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a QC Lead to ensure compliance with established procedures in analytical method validation and testing. Responsibilities include planning quality testing, leading investigations, and overseeing method development. The ideal candidate has at least 8 years of experience in pharmaceutical laboratories and proficiency with analytical methodologies such as HPLC and GC. Strong leadership and problem-solving skills are essential for success in this role.

Qualifications

• Minimum of 8 years experience in Pharmaceutical laboratories.
• Hands-on experience with analytical testing methodologies.
• Strong understanding of ALCOA+, FDA regulations.

Responsibilities

• Plan cGMP compliant quality testing and documentation.
• Review analytical results for raw materials and finished products.
• Lead OOS and atypical results investigation.

Skills

Leadership

Analytical testing

Problem-solving

Attention to detail

Education

Bachelor or above in Chemistry, Microbiology, Pharmaceutical Sciences

Tools

HPLC

GC

FTIR

Dissolution tester

Particle size analyser

Empower

LabX

LabSolution

Job description

About

The QC Lead ensures that the analytical method validation and routine analytical testing are in compliance with established procedure, health, safety and environmental standards, cGMP and regulatory standards, and current compendial methods. The incumbent will oversee laboratory activities on method validation, routine analytical tests troubleshooting and investigation for raw materials, excipients, active ingredient, intermediates and finished products. At the same time, QC Lead in analytical testing support to Production process validation and cleaning validation, introduction of new product testing method development.

Responsibilities

• Planning and assurance of cGMP compliant quality testing and documentation according to schedule, this includes but not limited to method development, method validation, cleaning validation, compendial method compliance.
• Review of routine analytical results for testing of raw materials (APIs, excipients), packaging components, in-process control, intermediates, finished products and stability samples.
• Ensure all analytical records following ALCOA+ requirement.
• Lead Out-Of-Specification (OOS) and atypical results investigation and troubleshoot analytical testing related issues. Implement preventive and corrective actions when needed and follow up the effectiveness check.
• Ensure analytical instrument qualification and method verification to meet GMP standards.
• Lead analytical method development, method validation / verification activities and ensure it complies cGMP standards and regulatory requirement.
• Report and trend analytical test results. Support analytical data for annual product review.
• Collaborate in reviewing and revising Standard Operating Procedures (SOPs) and testing methods to ensure continued compliance.
• Maintenance and development of all required laboratory documents (i.e. specification, analytical methods, safety data sheets, raw data sheets, logbooks).
• Responsible for laboratory computerized system setup and qualification, ensure electronic raw data handling in compliance with regulations and guidelines.
• Responsible for inspection and audit preparedness with respect to cGMP and EH&S issues.
• Other responsibilities that are not included in the above but are related to quality control operation, continuous improvement, and in accordance to internal guidelines and SOP.

Qualifications & Skills

• Bachelor or above in Chemistry, Microbiology, Pharmaceutical Sciences, or a related field.
• Minimum of 8 years experience in Pharmaceutical laboratories for testing of finished products, active pharmaceutical ingredients, excipients, packaging materials within a pharmaceutical or GMP-regulated manufacturing environment.
• Hands-on experience with analytical testing for materials and analytical methodologies such as HPLC, GC, FTIR, dissolution tester, particle size analyser etc.
• Must be able to lead laboratory investigation, root cause analysis and hands-on testing troubleshooting style.
• A good knowledge of ALCOA+, FDA regulations, PIC/S GMP guide, compendial methods, new product method development, analytical testing methods for process validation, cleaning validation is required.
• Strong understanding of QC instrument methods setup, computerised system including Empower, LabX, LabSolution setup, audit trail review, method validation and analytical transfer processes.
• Knowledge of analytical data analysis, interpretation, reporting and statistical trending.
• Experience in preparing for and supporting regulatory GMP inspections.
• Excellent attention to detail, communication, and problem-solving skills.