Quality Compliance Coordinator (Temp.)

Job Description Summary

Job Description Summary
To ensure that Sandoz quality standards and the obligations of the Ministry of Health and International Health Authorities are fully and continuously met in Nitrosamine Laboratory and areas in the scope of Quality Compliance System, to contribute to the achievement of Quality System and Compliance Department performance targets, to be at the top in terms of reliability, quality service and performance criteria

Job Description

Major accountabilities: 

• GMP abiding and ensuring compliance to the Health, Safety and Environment Policy

• Completion of All Trainings Assigned to Role

• Ensure integrity of Data at Workplace

• Ensure Good Documentation Practices at Workplace

• Give the report to the Quality System and Compliance Manager for Nitrosamine Quality and GxP related matters

• Manage and support all Quality issues and projects in the Nitrosamine laboratory

• Ensuring the recording and tracking of unexpected situations (OOX- Deviation-TTI) happened during analytical studies in accordance with the relevant SOP

• Arrange routine Nitrosamine walkthroughs and reporting

• Timely processing and resolution of deviations

• Improvements to minimize deviations

• Timely delivery of quarterly reports for Deviation and OOX

• Key user GXQEM for the new Gebze GXQEM entity

• Review and approve all open OOXs, Deviations, CAPAs and TTIs in Gebze Nitrosamine lab

• Improvement of root cause investigation for OOX&deviations

• To ensure assignment and follow-up of corrective and preventive actions

• Open escalations in GXQEM for all OOX detected in Gebze and also external lab

• Attend escalation calls opened by him/her and follow the incident history

• Attend weekly Gebze Drumbeat meetings

• Review and approve all reports, protocols, SOPs and documents generated by Gebze2 Nitrosamine Laboratory in eSOPS

• Review and approve all change requests opened by Gebze Nitrosamine Lab in the system

• Approve all re-qualifications, calibrations, maintenance, instrument related documents in Gebze Nitrosamine

• Review and approve validated excel documents generated by Gebze Nitrosamine

• Support to Lab OpexCertification, GreenLaband 5S Projects

• To ensure that Quality Agreements with the suppliers of the materials and service are in place and kept up to date

• To ensure that self-inspections are performed according to plan and actions are followed and updated

• To ensure that mock audits are performed prior to external audits and deficiencies are eliminated

• Delegation of his or her responsibilities, as and when required authorized persons in Quality System and Compliance

• Ensuring the design, implementation, monitoring and continuity including continuous improvement of an effective Quality Management System ensuring that intended objectives and results are met

• Promote use of risk-based thinking

• Determining and providing adequate and appropriate resources and the required infrastructure to implement and maintain the quality management system and continually improve its effectiveness

• Ensuring a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management

• Manage the implementation of Sandoz Policies & Global SOPs to ensure quality processes are maintained and current

• Conducting management reviews of process performance and product quality and of the quality system

• Monitoring of compliance with good manufacturing practices requirements

• To ensure that the necessary training is organized for the Gebze2 Nitrozamin personnel in accordance with the needs regarding the processes for which he/she is responsible, and to follow up the training processes

Key performance indicators:

• On-time and GMP-compliant release of dosage forms

• No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand

• Successfully support continuous improvement projects

• Executes batch release in compliance with registration 

• Meet QA related Nitrosamine KPIs&Quality Plan targets

• To ensure thorough and timely investigation of quality deviations, determination of root cause

• To ensure assignment and follow-up of corrective and preventive actions

• To ensure that proper actions are determined and followed up

• To ensure leading the escalation process in Nitrosamine lab

• Approve all re-qualifications, calibrations, maintenance, instrument related documents in Gebze Nitrosamine

• No HS&E incidents

Minimum Requirements: 
Work Experience:

• Functional Breadth

• QC/ QA experience in pharmaceutical industry

• Collaborating across boundaries

• A very good command of GMP

Skills:

• Continuous Learning

• Dealing With Ambiguity

• GMP Procedures

• Quality Control (QC) Testing

• Quality Standards

• Self-Awareness

• Technological Intelligence

• Technical knowledge of pharmaceutical

• Higl level of decision-making authority

Languages:

• English

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Global leader in generic and biosimilar medicines, operating as an independent company spun off from Novartis. Based in Basel.

sandoz.com