QC Associate (Key User)

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main responsibilities:

• Being representative of the site in the Business Operating Communities (BOC) related to QC digital core models, led by the global, in his/her scope and ensuring local communication.
• Executing local deployments of QC digital solutions (core model and local), in accordance with defined deployment plans and validation protocols.
• Issuing all local documentation related to QC digital solutions in scope, required to ensure their usage and maintenance in an appropriate way.
• Providing training and support of end-users on QC digital tools (in coordination with Sanofi global teams for core models).
• Maintaining and updating master data and end-user access to the QC digital tools, according to defined requirements and documentation.
• Informing his/her manager of any event related to digital systems in scope in a timely manner to ensure investigation and impact assessment are performed appropriately.
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately.
• Executing assigned CAPAs related to remediation plans, mitigation plans and continuous improvements.
• Support annual method review in the framework of annual product review
• Support the invalid assay trending program in the QC laboratory.
• Lead compendial compliance assessment and adherence for the QC laboratory.
• Lead periodic analytical method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate.
• Support the execution of qualification and maintenance operations related to QC equipment of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Ensuring all QC equipment are properly qualified and maintained for their intended use.
• Contribute to the compliance of laboratory GXP asset qualification and maintenance with applicable regulatory requirements and company quality standards.
• Contribute to the proper documentation, issuance, review, and approval of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
• Providing support during regulatory inspections and audits by presenting equipment management and Method validation documents and records.
• Leading initiatives for continuous improvement in QC support processes related to lab equipment management.
• Writing/reviewing protocols, user acceptance test (UAT) and reports related to analytical validation/transfers and qualification activities.
• Participate in Change Control Request facilitation and management in relation to QC test methods.
• Provide technical system administrator support for QC GXP laboratory computerized systems.
• Assume role of SME for Labware LIMS and collaborate closely with global site functions to address changes
• Ensuring laboratory instruments and facilities are kept in a quality and safety status to ensure that they can be used appropriately.
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks.

About you

• Bachelor’s degree in Chemistry, Pharmaceutical Science, Biotechnology, Engineering, or a related field.
• Relevant experience in pharmaceutical Quality Control or a regulated GxP laboratory environment.
• Experience with QC digital systems, LIMS, computerized systems, equipment qualification, analytical method validation, or method transfer.
• Good knowledge of cGMP, data integrity, deviation, CAPA, change control, and validation requirements.
• Strong analytical, documentation, communication, and stakeholder management skills.
• Able to work independently, support end users, deliver training, and collaborate with local and global teams.
• Fluent in written and spoken English.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including health insurance, out-patient benefits along with a range of family friendly policies such as maternity, paternity, and solo parent leaves to name a few.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!