About Sanofi :
The Firm is one of the TOP MNC located across the globe and is a biopharmaceutical company. The firm rated as top global employer certified for the year 2021.
About the Job :
Experience : Minimum of 14+ years of experience in QA with the Sterile manufacturing experience and bachelors degree
Job Responsibility :
Provide Quality inputs for facilities during design/project phase.
To ensure QbD concept right from bingeing of product life cycle.
Contributing to team effort by accomplishing results as needed.
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Tracking, reporting of quality performance indicators (KPIs) that measure the quality and compliance on a routine basis and identified risks related to quality and compliance
To assist in development of strategic and technical quality plans on support of the GMP.
Address quality related issues and report key findings to Site Quality Head.
Responsible for defining, implementing, managing and controlling all quality assurance systems in order to ensure quality of the product in compliance with established procedures and regulatory requirements
Ensure that adequate controls on starting materials, intermediate products, and bulk products, finished products and other in-process controls, calibrations, and validations are carried out.
Represent QA at project(s) and Sanofi review meetings.
To ensure compliance of global quality documents and regulatory requirements.
Leads Validation, IPQA, Sterility , Audit and Compliance and documentation vertical in QA function
Review and approval of master validation plan, drawings, layouts, URS, DQ, FAT, SAT,IQ, OQ, PQ, Technology transfer protocols/reports, Analytical method transfer protocols/reports etc.
To ensure documentation control for equipment and service providers.
Ensure product release according to established procedures and after certified by authorized person.
Work across all cross functions to ensure that the Company maintains a state of readiness for inspection by regulatory authorities
To review technical documents for quality, correctness and completeness.
To coordinate activities to ensure that goals or objectives of the project are accomplished within the prescribed time frame.
Conducting the risk assessment with cross functions where applicable.
To ascertain Quality of recalled product and performing in depth evaluation for reasons for recall
Ensure periodical verification of quality system by way of internal audits and handling of regulatory inspections, customer audits/GQA.