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

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 actionfolow 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 Requirement:

• 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.

Skills Desired Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Managing Resources, Organizational Savvy, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Smart Risk Taking, Technological Expertise, Total Quality Management

Skills Required