Qualification: masters in life science.
Experiences: 8 to 10 years.
QC compliance & QMS coordinator (QC IO)
Monitoring of Shop floor activities.
Monitoring the laboratory on daily basis to ensure that the Good laboratory practices are followed in the laboratory and no data integrity practices are followed in the laboratory.
To provide the training to shop- floor people with respective to the Good Laboratory Practices.
Participation in internal and external audits
Ensuring the laboratory is prepared for audit, Participation in the Audit and providing the support to the QC for the documents review, and providing the appropriate responses, CAPA and ensure that proposed activities are completed in the timely manner
By coordinating with the respective personal for the completion of QMS activities within target dates and by regularly tracking the COT files
Organising Cross functional meetings to ensure smooth QC operations and workflows
Responsible for Good laboratory practices across the entire QC laboratory and strengthening as per the regulatory requirements and GLP requirements.
Preparation of SOPs, STPs and reviewing the laboratory SOPs for compliance with the actual procedures being performed and recommending SOP revisions when necessary.
Monitoring, maintenance and calibration of Equipment's and instruments as per the schedule
Responsible for quality system compliance (Deviations, OOT, OOS, Invalidity, Change Controls, and CAPA) and implementation of global documentation for all QC functions
Interpreting data, analyzing results using statistical techniques like Normality test, Statistical process control, Correlation, Regression, etc.
Design and validation of GxP Excel spreadsheets
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.