QC Associate (System)
About the job
The QC associate is a member of the QC system team reporting to the QC Supervisor (System). The incumbent support analytical method validation and analytical instrument lifecycle validation projects according to cGMP and GLP regulations.
The team works well together and collaborates to deliver site objectives.
Assist in method validation and transfer, as required.
Assist in analytical instrument / equipment lifecycle management through implementing appropriate QC systems, selection of appropriate lab equipment for purchase through authoring and documentation of details URS, involve in instrument / equipment qualification, reporting, drafting and implementing SOP’s for system operation and maintenance, monitoring performance of the equipment, decommissioning of equipment.
Assist in ensuring that systems, critical methods etc. setup within the analytical section complies with cGMP requirements regulatory requirements, corporate policies, compendia and site SOP’s.
Assist in maintaining the asset register for equipment, CS Inventory in the QC lab.
Assist in carrying out maintenance / calibration records of laboratory instruments / equipment in compliance with established schedules.
Assist to liaise with vendors/service providers for PM / Calibration in a timely manner. Will be responsible for the calibration planner within QC.
Maintenance and development of all required laboratory documents (i.e. raw data sheets, log books).
Responsible for electronic raw data handling in compliance with regulations and guidelines.
Provide technical advice if needed in his/her area of responsibilities.
Assist in improving and maintaining test methods and equipment (i.e. qualification, validation and transfer).
Assist in initiating and driving continuous improvement initiatives related to systems in laboratory.
Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and HSE aspects.
Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety.
Play a pro-active role in ensuring the HSE standards & Life Savings Rule are adhered to. Embrace Zero Incident Mindset and adopt the responsible of HSE
protection policies and Life Saving Rules (LSR). Practice safe laboratory operations and ensure all HSE procedures are followed.
Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP.
Experience: QC laboratory experience in pharmaceutical industry. Able to support laboratory investigation via hands-on troubleshooting style.
Soft skills: Strong written and verbal communication skills
Technical skills: Good working knowledge in Laboratory instrument qualification and computer system validation. Good knowledge of Health Authorities regulations and cGMP
Education: University degree in relevant scientific discipline; Diploma holders with more than 3 years relevant working experience can be considered.
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.