Senior Expert

Novartis; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a Quality Control professional to manage operational activities and ensure compliance with regulatory standards. The role encompasses release testing, team coordination, and leadership in operational projects. Candidates should have experience in quality monitoring and regulatory compliance, making significant impacts in process improvements. Join a community dedicated to helping patients and their families thrive.

Qualifications

• Experience in quality control and monitoring of processes.
• Familiarity with cGxP requirements and regulatory compliance.
• Capability in coordinating departmental activities.

Responsibilities

• Perform tasks associated with release testing and laboratory data review.
• Coordinate team/lab activities and manage hiring processes.
• Lead Operational Excellence projects and define improvement areas.

Skills

QC of products

Micro bio analytics

Process and facilities monitoring

Regulatory compliance

Team coordination

Job description

Summary

Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data, coordinating the 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

Key Responsibilities:

• For QC/A S and T, AS required, based upon size of site / span of Control.
• Coordination of departmental Operational activities (listed in QC Head role).
• Initiate and drive local hiring process.
• Line responsibility and daily walkthrough.
• Lead OpEx Projects.
• Investigation of Deviation, OOx, Complaints.
• Define and implement CAPAs.
• Support transfer Projects and validation studies.
• Track team metrics and ensure KQI /KPI meet requirements.
• Review and approve text and design.
• HSE incidents reporting and action follow up.
• 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 and revision.
• Ensure training according to cGxP requirements.
• Exception management, Complaint Investigation Support.
• Ensure DI and compliance with cGxP and all regulatory requirements.
• Collaboration in GxP internal audits and ensure fulfillment of internal/external audit and inspection plans.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements

• QC of products & monitoring of processes and facilities; timely handling & settlement of deviations.
• Timely update of SOPs.
• Timely delivery of documents.
• Timely delivery of registration documents.
• Coaching tasks; compliant archiving.
• No avoidable safety incidents.
• Cost control and delivering key figures for QC with agreed timelines.
• Yearly training schedule.
• Collaborating across boundaries.
• Micro bio analytics/ diagnostics inc. growth properties QC/ QA in pharmaceutical ind./ biotech with environmental monitoring & micro-organisms & culture media prep. cleanliness zones.

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?

Location & Company Details

Division: Operations

Business Unit: Quality

Location: Singapore

Site: Tuas South Avenue

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

Commitment

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