About the Role
QC Specialist ensures that the analytical method and testing are in compliance with established procedure, health, safety and environmental standards, cGMP and regulatory standards. The incumbent will perform routine analytical tests for raw materials, excipients, active ingredient, intermediates and finished products. The person will also be involved in instrument qualification, analytical method validation and support to Production process validation.
Responsibilities
Startup Phase:
- Assist in the setup of the new manufacturing plant and QC lab, ensuring all necessary equipment, materials, testing methods, and procedure are in place for smooth operations.
- Collaborate with teams to source materials, equipment, and contract laboratories to support analytical and microbiological testing, and manufacturing needs.
- Assist to establish Environmental Monitoring (EM) qualification programs and utilities qualification to ensure facility cleanliness and microbial control per GMP standards.
- Perform analytical and microbiological testing related instrument qualification and method verification to meet GMP standards.
- Perform analytical method validation / verification activities to meet GMP standards.
- Ensure QC readiness to support testing and release for raw materials, in-process samples, finished products, water and environmental samples.
Routine laboratories operation:
- Planning and assurance of cGMP compliant quality testing and documentation according to schedule.
- Perform analytical testing and/or microbial testing of raw materials (APIs, excipients), packaging components, in-process control, intermediates, finished products and stability samples.
- Checking the accuracy and completeness of test results on analytical data sheets.
- Assist in Out-Of-Specification (OOS) and atypical results investigation and troubleshoot analytical testing and microbiological related issues.
- Implement preventive and corrective actions when needed and follow up the effectiveness check.
- To ensure that qualification, preventive maintenance and calibration of laboratory instrument are carried out as per schedule.
- Manage laboratory housekeeping, reagent and consumable inventory, and waste disposal.
- Management of reference standards and stability samples.
- Report and trend analytical test results.
- 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, log books).
- Responsible for 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
- Diploma or above in Chemistry, Microbiology, Pharmaceutical Sciences, or a related field.
- Specialist requires minimum of 3 to 5 years of experience in chemistry in a pharmaceutical or GMP-regulated manufacturing environment.
- Hands-on experience with analytical testing for materials (raw materials, API, excipients, packaging, finished product), water testing and environmental monitoring testing in QC and/or microbiological lab.
- Hands-on experience in analytical methodologies such as HPLC, GC, FTIR, dissolution tester etc.
- Must be able to adopt hands-on troubleshooting style.
- A good knowledge of FDA regulations and cGMP is required.
