Have previous working experience in cGMP laboratory environment
Reviews and approves all required Chemistry testings and ensures that tests are performed in accordance with corporate, regulatory and external agency regulations.
Enforces all laboratory policies and practices and that all in-use procedures are current and compliant.
Supports equipment/software/method validation and performs (re)validation when necessary.
Writes required GMP documentations such as SOPs, protocols, reports, deviations, change controls
Knowledge is transferred effectively to routine testing team e.g. training
Requirements:
Science Degree in Chemistry or equivalent with more than 2 years of laboratory experience, preferably in the pharmaceutical industry.
Diploma holders with more than 5 years of laboratory experience in the pharmaceutical industry.
Competent technical skills in the following:
Common laboratory techniques (e.g. HPLC, GC, AAS, autotitrator)
Hands-on experience in Chemistry testing (advantage)
Laboratory equipment qualification
Method Validation
Computer System Validation
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239
