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Job title : Head- Quality Assurance
40% Remote working and 20 % of travel expected
Job type: Permanent
Our Team:
External manufacturing India is managing Sanofi products manufactured at CMO’s (Contract Manufacturing Organizations) located in India and other Asia pacific region. EM India is managing various types of formulations including solid orals, semi-solid, liquids and parentals. Our team is managing activities related to manufacturing, Quality, Regulatory and supplies of products manufacturing at CMO’s.
Purpose:
Ensuring implementation and monitoring of the Quality systems at Sanofi’s External manufacturing sites as per cGMP and Sanofi Global quality document requirements in order to ensure the quality of products delivered to market.
Our Mission:
We Lead and manage the Quality strategy within the External Manufacturing site’s network to ensure that drug products manufacturing and distribution activities are in compliance with the Global Quality standards and applicable regulatory requirements.
Main responsibilities:
Operational Management of CMOs:
Lead and manage the Quality operations team, ensures the cGMP and Quality Management Compliance at CMOs.
Management and ensuring Operational activities of pharmaceutical products at identified CMOs comply with the requirements of the Sanofi Quality directives and meet all relevant cGMP & regulatory requirements.
Monitor and ensuring that all the drug products are timely released in accordance with the registered specifications and in accordance with local regulations.
To ensure validations, qualifications at CMO site.
Ensuring the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems.
Participate and guide QA managers team for appropriate evaluation and implementations of Quality compliance at CMO’s.
Ensuring the CMO compliance as per the respective Quality Agreements.
Quality Management System:
Ensuring the QMS systems compliance as per the Sanofi Global procedures.
Participates in evaluation and defining CAPA / action plan / Investigations, alignment and implementation at CMO sites.
Responsible for assessing and approval of Quality trends through APQR’s and driving Continuous improvement for processes and product quality performance.
Investigations of Product technical complaints for products manufactured at external manufacturing sites.
Management of quality Escalation of events, initiated from any of the quality system.
Identify, control and escalation of proactive risk at CMOs.
Regular oversite the hub activities to ensure the compliance and adherence to the KPIs.
CMO Quality reviews:
Responsible for executing and ensuring the site quality reviews as per the SQR calendar and highlighting the potential observations & actions plan to the management. Ensure implementation of action plan in timely manner.
Define and ensuring the implementation of Quality improvement plan for CMO’s.
Quality Agreements:
Ensuring Quality & Regulatory compliance and Inspection at CMO’s:
Ensuring Quality and regulatory compliance at CMO’s, by On-Site Quality review as per planner and ensuring implementation of registered Dossier at site.
Ensure audit readiness at CMO for regulatory audits at CMO’s.
Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.
Perform Quality Risk assessment:
Responsible for identifying the Risk and investigating for identifying potential quality risk and assigning appropriate CAPA for risk raised/identified for CMO’s.
Conduct the CMO risk ranking as per the frequency for the assigned CMO’s. Timely discuss and align the Action plan for the improvement of CMO risk ranking with EM India management.
Other Key Quality Responsibilities:
Implementation of Global procedures through impact assessment.
Monitoring of Quality KPIs and identify to take action (if any required)
Evaluate the new drug product sites, ensuring Due Diligence for new product evaluation and follow up on compliance to ensure the timelines of product launches from CMO.
To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management.
Ensure smooth analytical and manufacturing transfer through close working with transferring site and receiving site.
Post audit assessment of CMO and supplier as a requesting site.
Ensuring product artworks review and compliance of current artworks at CMO.
Ensure a cross-functional alignment within Sanofi, and with the assigned CMOs to control all processes required for receiving products from CMOs in terms of quality, compliance, time, volumes, and costs during the overall contract life cycle.
About you:
Experience : (>12 years of experience in Quality Assurance, 2-4 years team handling)
Soft skills : Team handling, Stakeholders management, Effective communication with external partners -CMO's, and ability to work independently.
Technical skills : Quality Assurance, Quality Control, Effective Analyzing skills, Strong cross-functional collaboration, teamwork, and stakeholder management. Handling of different pharmaceutical dosage forms
Managerial courage – ability to make difficult decision and implement successfully
Education : (B.Pharm/ M.Pharm/ MSc/PhD in lifesciences)
Languages : English, Hindi
Beware of Job Scams: Sanofi Fraud Notice:
As you conduct your job search, please beware of the possibility that scammers may post fraudulent job openings or send fraudulent communications (email, SMS, WhatsApp or Messenger messages pretending to be from Sanofi) regarding potential job postings or offers in an attempt to encourage the job seeker to disclose financial or personal information. We do not make any payments to or ask candidates for any fees as part of the application process. In most cases you can expect to hear directly from a member of our recruiting team with a legitimate @sanofi.com email address, but you may receive communications from one of our recruiting partners as well. Consequently, you should always conduct research to ensure a posting and/or offer is legitimate and you should never provide personal or financial information unless you are certain that the request is legitimate. If you are concerned that an offer of employment with Sanofi might be a scam, please verify by searching for the posting on the Careers webpage
Pursue progress, discover extraordinary:
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, disability, or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Pursue progress , discover extraordinary
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)