Summary

-Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data, coordinating and leading the Micro team/lab under its responsibility. Communicating with internal & external partners for the Quality Control organization. Supports site as technical expert in related field

About the Role

QC Team Leader - Microbiology

Location - Singapore

About the Role:

Responsible for operational leadership of a defined area / laboratory within the site's quality control unit. Ensure compliance with all cGxP, regulatory and HSE aspects as well as responsible for people leadership within are of responsibility.

• Coordination of departmental operational activities on behalf of Site QC Lead (details see role profile QC Lead). Management of microbiological activities in line with site objectives
• Line responsibility and daily walkthrough. Lead OpEx Projects. Investigation of Deviation, OOx, Complaints.
• Define and implement CAPAs. Support transfer projects & validation studies
• Track team metrics and ensure KQI/KPI meet requirements. Review and approve text and design. New equipment commissioning support (OQ, PQ). Define improvement areas in process and products.
• Resource and capacity (people and equipment) planning and workload management. Performance and leadership support to specialist team. Ensure availability of equipment, chemicals and consumables, as appropriate. SOP review & revision. Perform local training and monitor training status.
• Planning of activities. Daily supervision of activities. Document approval. Leading execution of daily plan. Microbiological testing review and approval.
• Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibility.
• Invest time in personally developing and coaching talents. Actively support and promote talent exchange for the benefit of the individuals and organization. Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates.
• Ensure that associates are qualified for a GMP task prior to independent performance. Monitor overall training compliance for in-scope associates. Identify and maintain a list of subject matter experts for in-scope areas of expertise.
• Create a work environment that enables high employee engagement. Role model the culture aspiration of being Curious, Inspired and Un-bossed

• Biological/microbiological analytics or diagnostics including growth properties of micro-organisms and culture media preparation; quality control/ assurance in pharmaceutical industry or biotechnology, especially with regard to environmental monitoring and cleanliness zones.
• Collaboration; result-oriented. Project management. Lead, plan, manage, and coordinate personnel
• Breakthrough Analysis; Operational Excellence; Interpersonal Savvy. Organizational Savvy; Being Resilient.
• GMP, HSE and 5S guidelines/regulations and SOPs; Cost control. Managing resources; Laboratory equipment; Quality Control (QC) Testing. Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
• MS Office applications and other standard IT applications supporting Quality activities

• University degree with a scientific / technological background (e.g. Microbiology, Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).