Senior Analytical Team Leader
23 hours ago
Job Overview
">- This role is responsible for leading large teams in the Quality Control (QC) department, including the Analytical Method Validation (AMV) team. The primary objective is to lead LC-MS, Nasal analytical, and FT-NIR analytical teams for regular testing/method validation activities.
- Secondary responsibilities include providing backup support to the QC Head of Department (HOD) with daily updates, monthly sample status, lab management, training, monthly review meetings, and coordination with all stakeholders to align work as per requirements.
Key Responsibilities
">- Lead the QC-AMV team size of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities.
- Provide backup support to the QC HOD with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with all stakeholders.
- Execute and approve different types of Quality Management Systems (QMS), identify scientific root causes, and maintain lab compliance.
- Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and presenting to the HOD.
- Ensure a self-driven approach, capability to make self-decision, and be a good learner. Provide guidance to team members for improving work quality and monitor/report on key performance indicators (KPIs).
- Responsible for leading all types of 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 like QA, RA, R&D, and PMI to proceed allocated tasks with ownership and accountability.
- Stay updated on industry developments and emerging trends to ensure a competitive position for LC-MS and FT-NIR techniques.
- Adhere to Good Laboratory Practice (GLP) and Health, Safety Environment system in the laboratory and face FDA Audit (US, MHRA, EU) individually.
Qualifications and Pre-Requisites
">- Master's Degree of Science/Bachelor's or Master's Pharma.
- Strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, Nasal performance testing etc) with ability to interpret complex data and generate insights.
- Mix work experience in QC, AMV, and AD departments.
- Strong leadership skills with proven ability to motivate and develop team members.
- Exceptional problem-solving skills and strategic mindset. Solid organisational and time management skills with ability to manage multiple projects and deadlines.
- Knowledge of Chromeleon 7.2 and Sciex software will be an added advantage.
- Good working experience in GMP and USFDA/EU Audit faced.
- Skill to achieve deliverable tasks with minimum support for analysis.
- Excellent written and verbal communication skills with ability to present findings clearly and effectively.
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