About this role
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
Job Description Major accountabilities:
• 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. • Perform local training and monitor training status -for Microbiological QC as above, plus: -management of Microbiological activities in Line with site objectives. • Ensure training according to cGxP requirements. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • management of documentation and Methods according to cGxP. • 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. • Equipment qualification review /release. • Ensure activities executed according to cGxP standars planning, Collaboration in GxP audits/inspections. • Ensure Methods and Procedures are up to date. • Management of documentation and Methods according to cGxP. • Ensure qualification /calibration status of analytical equipment. • Ensure compliance of products and other materials with specifications and with corporate, health authorities, and E5 requirements. • Microbiological testing review and approval. • Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators:
• 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 Minimum Requirements: Work Experience:
• Collaborating across boundaries. • (Micro)bio analytics/ diagnostics inc. growth properties of. • QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &. • micro-organisms & culture media prep. • cleanliness zones. Skills:
• Continuous 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. Languages:
• English.
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