QC Analytical Chemist

• Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure to make appropriate recommendations remedial actions for follow-up.
• Ensure that all data supporting the resolution of process and method issues have sufficient accuracy to allow for the correct actions to be taken to address the issue.
• Contribute to the formulation and development of the plans for the implementation of new testing technologies and methods.
• Involve in the approving change that may have an impact on product quality, validation and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change. Upon completion, review and ensure closure of changes.
• Draft, compile, review and update appropriate laboratory documents such as testing protocol, procedures and guidelines relating to GMP and operational framework of the laboratory.
• Ensure regulatory compliance, perform Client's Management Monitoring audit and support Independent Business Monitoring (IBM) and external audits.
• Constantly monitor product quality and highlight the anomalies to the manufacturing group and higher management.
• Other preferences: prior experience of GMP work environment, Data Integrity knowledge, DMAIC

Qualifications

• Science‑based tertiary qualification, with preference for Chemistry or related disciplines
• 5-12 years of relevant working experience within a pharmaceutical or GMP‑regulated environment
• Strong technical competency in analytical chemistry techniques and laboratory practices
• Proven problem‑solving capability with the ability to apply scientific judgement to complex analytical issues
• Well‑developed influencing and interpersonal skills, with the ability to collaborate effectively across laboratory, quality, and client stakeholder