to assist the QC Manager/ Deputy QC Manager in overseeing and ensuring the running of all day-to-day activities related to the inspection of precision instruments in QC laboratory in compliance with company requirements and GMP guidelines;
to manage timely testing of precision instrumentation involved in raw materials, in-process and finished goods and provide recorded data;
to provide assistance to management in investigating OOS conditions of precision instrument related projects;
to supervise stability activities and complete precision instrument related tests within the specified time according to the test plan to ensure compliance with regulatory requirements;
to schedule, plan, perform and ensure that the assigned assigned precision instrumentation (e.g. HPLC, GC, ICP-MS) related validation and tasks are completed.
To establish procedures and specifications
to assist in establishing Standard Operating Procedures, method and specifications for starting materials, intermediate and finished products;
to develop validation and qualification documents such as Method validation protocol, URS, DQ, IQ, OQ, PQ, and others.
Tests or examinations/Others
to perform methods development and validation;
to perform equipment qualification;
to perform chemical and physical tests on APIs, excipients, packaging material, intermediate and finish product as per inspection plans and specification requirements;
to perform equipment calibration & maintenance;
to ensure the standards are prepared, continuously available, properly stored;
to interpret and report results of analysis;
to complete documentation accurately and according to cGMP;
Bachelors degree or above in Chemistry / Applied Science/ Pharmaceutical Study or equivalent.
Experience: Minimum 3 years practical experience working in a pharmaceutical Q.C. Laboratory or HOKLAS Laboratory.
Knowledge and Skill (Optional)
GMP , GLP , GDP, Laboratory safety, Gowning techniques, Sampling techniques, Uses and care of standard laboratory equipment, Laboratory methods and techniques, Methods and procedures for handling Dangerous Drug and Controlled substance.
Usual laboratory equipment. In addition: HPLC, GC, ICP-MS, Dissolution Tester, Disintegration Tester, etc. PC with specialized software.
