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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.
Key Responsibilities:
- 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
Essential Requirements:
- 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
Desirable Requirements:
- University degree with a scientific / technological background (e.g. Microbiology, Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
