Quality Specialist Complaint Management

Job title: Quality Specialist Complaint Management

• Location: Hyderbadad, India
• Job type: Permanent

About the job

Our Business and Team:

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”. We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast Moving Consumer Healthcare (FMCH) Company In & For the World”. Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu. To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

In EM CHC EULA we are focused on the achievement of the Excellence that is under leadership of the diverse team.

The position holder acts as Quality Assurance Specialist and on the first level of escalation to resolve Quality complaints promptly and to minimize the overall risk to the company.

The position holder ensures actively the Complaints management of the portfolio produced by Contract Manufacturing Organizations in line with current GMP and company requirements.

Important internal and external relations: CHC External Manufacturing Quality Assurance, CHC External Manufacturing Quality System, Global Quality External Manufacturing, Global Manufacturing & Supply, Supply Chain Managers, Quality System Excellence, Contract Manufacturing Organizations, Distributions Centers.

Main responsibilities: Complaint management of portfolio from Contract Manufacturing Organizations in line with current GMPs, and company requirements

• Supporting the Quality Assurance manager to ensure timely handling of product complaints.
• Take care of the EM CHC Europe complaint management inbox
• Ensure overview of incoming complaints and monitoring of due date at the CMO and EM CHC Europe site
• Assignment of incoming Complaints to the respective CMO
• Assessment ad categorization of the complaint
• Recurrence monitoring
• Corrective & preventive actions follow up
• Documentation of investigation in the system
• Closure of the complaint in the system
• Potential exchange with the affiliate
• Contribute to the monitoring / trending of complaints. 
• Monthly KPI evaluation and reporting
• Preparation of summary for Product Quality Reviews
• Contribute in the annual CMO Risk ranking exercise

About you

• Experience:

• 3 years in pharmaceutical environment, preferably in Quality, i.e. quality control/assurance, systems quality assurance and/or quality systems management
• experience in external quality management activities
• experience in management of CMOs, subcontractors / suppliers

• Soft skills:

• Ability to work in the diverse team (several locations)
• Communication skills
• Problem solving
• Being proactive
• Team work
• Strive for results
• Committed to customers

• Technical skills:

• Commit to customers
• Cooperate transversally
• Analytical and structured way of thinking, high sense of responsibility

• Education:

• Qualification in Pharmacy or Natural Sciences
• Good oral and written communication skills
• Sound knowledge of pharmaceutical regulations/GMP

• Languages: Good English language skills to effectively negotiate and communicate verbally and in writing

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!