The incumbent will be responsible for the management of all Quality Assurance and Release activities at the plant site. You will ensure the release of raw materials, components, intermediates, Active Pharmaceutical Ingredients and finished tablet products to demanding timelines without compromising the quality, safety and efficacy assurance of the products or the operations. Developing, documenting and maintaining Quality Release and related systems in accordance with Merck’s standards and FDA Quality Management Systems expectations (21 CFR Parts 210 and 211) and global regulatory expectations are also part of your role. Requirements • BSc/BA level in Chemistry or Chemical Engineering or equivalent • Minimun 7 years’ Quality Operations experience, with at least 5 years' in pharmaceutical manufacturing area • Detailed knowledge and understanding of Quality Assurance principles, FDA, PIC/S and EU Regulatory compliance expectations and ideally possess an awareness of emerging market regulatory issues • Knowledge of Lean/Six Sigma methodology and tools

企業介紹:
MSD Singapore- Your Right Career Choice! Do you want to help people live healthier lives? Are you a dynamic person who enjoys challenges? Do you want a rewarding working environment? MSD Singapore is your Right Choice! MSD (Singapore) Ltd is wholly owned subsidiaries of Merck & Co., which is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal healths. Located at Singapore Tuas Biomedical Park, the manufacturing facilities of MSD Singapore comprise of a bulk active pharmaceutical ingredient (API) plant and a pharmaceutical formulation plant.