Sr. Quality Control Team Coordinator

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