Qc Team Leader

4 days ago


Tuas, Singapore Novartis Full time

**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.
- 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

**Desirable Requirements**:

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

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas Bay Lane

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.


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