Key Responsibilites
- Perform method transfer, validation, verification, and cleaning method development/validation in compliance with GMP, GLP, and ALCOA principles.
- Conduct analytical testing, review test results, and ensure timely and accurate documentation per SOPs and Data Integrity standards.
- Assess and implement changes based on compendial monograph updates; support post-transfer regulatory activities.
- Lead and participate in lab investigations, CAPA development, SOP/OJT documentation, and hands-on method training.
- Collaborate with external sites to facilitate smooth method transfer and support method troubleshooting and optimization.
- Drive continuous improvement initiatives and actively contribute to lab safety, 5S, and Tier performance meetings.
Key Requirements
- Strong technical expertise in method transfer, validation, verification, and analytical testing.
- Proficient in handling lab instruments (HPLC, GC, FTIR, UV, KF) and knowledgeable of compendial standards (USP/JP/EP).
- Solid understanding of GMP, GLP, Data Integrity, and regulatory compliance.
- Effective communication, organization, and multitasking skills, with the ability to manage multiple projects.
- Familiarity with lean manufacturing, Six Sigma, and continuous improvement methodologies.
- Experience with regulatory submissions and authoring protocols, reports, and test procedures.
If you have what it takes, please send your resume to syafiqah@ambition.com.sg or click APPLY NOW. For more information, please visit www.ambition.com.sg. Data provided is for recruitment purposes only. Regrettably, only shortlisted candidates will be notified. Business Reg No : 200611680D | Licence No : 10C5117 | EA Reg No : R2199023