Sanofi want to build a healthier, more resilient world. We turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.
Post : Global Quality System Process Manager
Job Description
Main responsibilities
He/she will be responsible of a wholistic Quality System that includes:
• Ensuring a sustainable compliant and robust Quality Management System (QMS) meeting Good Pharmacovigilance Practices (GVP), regulatory and legal requirements
• Creates, enables and maintains a QMS which mandates from global to country level a state of control on monitoring and tracking systems with regards to pharmacovigilance activities
• Identifies potential risks of non-compliance and establishes and oversees improvement programs to mitigate the risks
• Ensures that the PV organization is inspection-ready and supports preparation, conduct and follow-up of inspections and audits
Key accountabilities
• Preparation and maintenance of Global Quality documents (QDs) applicable for CHC PV architecture in line with global quality directives and standards.
• Definition of the planning and execution of QD plans and QD lifecycle management (updates and periodic reviews)
• Make Quality documents available in timely manner in the Electronic Document Management System
• Management of Quality Events in the Electronic Quality Management System (i.e. deviation, CAPA, change control) in a timely manner
• Ensure process is in place to maintain the PV QD Training Matrix, training curriculum updated.
• Ensure global traceability and monitoring of investigations of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented in timely manner.
• Conduct or coordinate Quality Risk Management analysis, reporting and eventually, escalation and ensure appropriate and adequate traceability and documentation of quality risks.
• Perform trend analysis on quality audits results and deviations and analyze effectiveness of corrective/preventative action and re-adjust the measure.
• Coordinate/ lead vendor qualification standards and processes to track vendor assessments and oversee the level of quality of their deliverables.
Candidate Profile
• Experience : Professional experience in data management (transcription & verification) (preferable for report issuance)
• Soft skills : Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments
• Technical skills : Quality systems (e.g., Veeva, Kneat, LIMS), Word, Excel, Power Point
• Education : Bachelor's degree (preferably in Pharmacy, Chemistry, Biology, or related field)
• Languages : Excellent English communication and writing, French or other Languages in addition preferred
Additional Information
Qualification : Bachelor’s or master’s degree in life/ medical/ natural sciences
Location : Hyderabad, India
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th November 2024
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