
Director of Analytical Operations
2 days ago
Key Responsibilities:
- Lead a large team of 30+ members in Quality Control (QC), including an Analytical Method Validation (AMV) team.
- Provide backup support to the QC Head of Department with daily updates, commercial output, monthly sample status, training, and coordination with stakeholders to align work as per requirements.
- Execute and approve various types of Quality Management System (QMS) initiatives, such as Out-of-Specification (OOS), Out-of-Trend (OOT), investigations, and corrective actions, and maintain laboratory compliance.
- Design and execute planning for analysis, data interpretation, and presentation to senior leadership.
- Monitor and report on key performance indicators (KPIs).
- Take charge of 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 Quality Assurance (QA), Regulatory Affairs (RA), Research and Development (R&D), and Project Management Institute (PMI) to proceed with allocated tasks with ownership and accountability.
- Stay updated on industry developments and emerging trends to ensure competitiveness for Liquid Chromatography-Mass Spectrometry (LC-MS) and Fourier Transform Near-Infrared (FT-NIR) techniques.
- Maintain adherence to Good Laboratory Practice (GLP) and Health, Safety, Environment systems in the laboratory, and face FDA audits individually.
Qualifications & Requirements:
- Bachelor's or Master's degree in Science or related field.
- Strong analytical knowledge and expertise in modern analytical instruments, such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), LC-MS, NIR, or Nasal performance testing.
- Preferably mixed work experience in QC, AMV, and AD departments.
- Strong leadership skills with a proven ability to motivate and develop team members.
- Exceptional problem-solving skills and strategic mindset. Solid organisational and time management skills, with the ability to manage multiple projects and deadlines.
- Familiarity with Chromeleon 7.2 and Sciex software is an added advantage.
- Good working experience in GMP and USFDA/EU Audit faced.
- Able to achieve deliverable tasks with minimum support for analysis.
- Excellent written and verbal communication skills, with the ability to present findings clearly and effectively.
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