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.

the experience

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.

senior qc / qc analyst [pharmaceutical]

personal details

wendy tay