About the role
As a QA Batch Review Specialist within our Quality Assurance Operation Team, you will ensure compliance with regulatory requirements and GMP standards in all batch release activities. You will be responsible for ensuring that all processes within your scope comply with applicable regulations and that Good Manufacturing Practice is maintained. Ready to get started?
About Sanofi:
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Key Responsibilities:
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Ensuring that activities within their scope are carried out in accordance with applicable regulatory requirements
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Ensuring that all batch release activities comply with Good Manufacturing Practices (GMP)
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Reviewing batch records and associated documentation
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Promoting a quality culture and continuous improvement throughout the company
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Participating in internal and external audits and regulatory inspections for support and documentation
Important involvement in the decision-making process
Key roles (D,A,I):
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Prioritization of quality and compliance goals (D)
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Approving a batch record if it is correctly completed and meets the quality requirement for a batch (D)
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Checking whether all practices are carried out according to quality requirements; if not, ensuring that a deviation is opened and reported in the batch record (D)
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Reviewing documentation for batch disposition (A)
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Advising on initiatives to promote a quality-oriented culture (A)
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Advising on the presentation of a topic and answering specific questions (A)
Local specifics / Additional responsibilities:
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Responsible for archiving batch records after batch release and for storing and requesting batch records from the external archive.
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Adhere to the Life Saving Rules and all HSE requirements related to their activities.
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Are empowered to identify, correct, and immediately report unsafe conditions, hazardous behaviors, or potentially dangerous situations.
About you
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Experience: Experience in the pharmaceutical industry, particularly in a GMP environment and SAP environment
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Soft skills / Technical skills: Teamwork, willingness
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Education: Pharmaceutical technician or comparable training, training in the pharmaceutical-chemical or scientific field
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Languages: Very good German skills and good written and spoken English skills
Why should you choose us?
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Discover the wonders of science with an innovative team to improve people's health.
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Find diverse opportunities in an international working environment to develop your talent professionally and personally and to continuously advance your career through internal changes and role expansions. Individual and structured onboarding is a matter of course and begins even before your first day.
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An attractive, market-oriented compensation and benefits package, including a company pension scheme, rewards your experience and contribution.
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Start your career at an attractive location in the middle of Germany and experience our modern working environments. For your commute to work, you will be supported by an individually usable monthly mobility budget.
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
Compensation is based on the federal collective bargaining agreement of the chemical industry.
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.