
Principal Scientist
7 days ago
- Lead the QC-AMV team for regular testing/method validation activities, utilizing sound analytical knowledge and leadership skills to achieve company goals.
- Provide backup support to the QC-HOD, including daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with stakeholders.
- Execute and approve different types of QMS, identify scientific root causes, implement effective CAPA, and maintain lab compliance.
- Design and execute analysis plans, interpret data, and present findings to the HOD.
- Self-motivated, capable of making decisions, and a good learner. Provide guidance to team members to improve work quality, monitor, and report key performance indicators (KPIs).
- Lead all QC-AMV work in the absence of the QC-HOD and actively participate in departmental improvement programs to enhance output and quality.
- Collaborate and coordinate with cross-functional teams (QA, RA, R&D, PMI) to proceed with allocated tasks with ownership and accountability.
- Stay updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
- Ensure adherence to GLP and Health, Safety, Environment systems in the laboratory and be prepared to face FDA audits (US, MHRA, EU) individually.
A Master's Degree in Science or Bachelor's/Master's in Pharma is preferred. The ideal candidate should have strong analytical knowledge, expertise in modern analytical instruments (HPLC, GC, LC-MS, or NIR), and the ability to interpret complex data and generate insights.
Strong leadership skills, a proven ability to motivate and develop team members, exceptional problem-solving skills, strategic mindset, solid organizational, and time management skills are essential. Knowledge of Chromeleon 7.2 and Sciex software is an added advantage. Good working experience in GMP and USFDA/EU audit faced is desirable.
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