Senior QC / QC Analyst [Pharmaceutical]

We are currently looking for Senior QC / QC Analyst for a leading player in the Pharmaceutical Manufacturing Industry with a legacy of more than 60 years in the world. This position requires your urgent attention.

• Reporting to: Quality Manager
• Excellent remuneration and benefits package
• Based in Johor

the job

• Effectively implement SOPs, test methods, and relevant documentation for raw materials, in-process, finished product validation, and stability testing.
• Coordinate the successful execution of Method Transfer activities for nnewly introduced methods in QC laboratory.
• Perform expert testing in assays, content uniformity, impurities, moisture, particle size, and more.
• Utilize a range of laboratory instrumentation and equipment (e.g. Analytical balances, pH meter, Gas Chromatography, etc)
• Manage documentation preparation and coordination (protocols, reports, procedures) across departments.
• Keep precise and organized laboratory notebooks, ensuring adherence to good documentation practices (GDP).
• Spearhead laboratory investigations into out-of-specification (OOS) and out-of-trend (OOT) incidents.
• Oversee the calibration and maintenance of equipment used for testing raw materials and finished goods.
• Prepare and review Certificates of Analysis (COAs) and stability reports.
• Coordinate the sourcing and purchasing of materials for raw material/product testing, working closely with suppliers and vendors.
• Ensure compliance with ISO procedures, safety standards, and regulatory requirements in all processes.
• Support continuous improvement initiatives, lean projects, and drive quality enhancements across the organization.

• Bachelor’s degree in Chemistry, Science, Biotechnology, Biochemistry, or other related fields.
• At least 5 years of quality assurance experience in Pharmaceutical Manufacturing.
• Self-motivated, capable of managing multiple deadlines and prioritizing tasks effectively.
• Solid knowledge of analytical testing methodologies.
• Comprehensive knowledge of regulatory standards, GMP, GLP, and ISO 9001.
• Proficient in 5S methodology, SOP development, and data analysis.