Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

For our team in Friesoythe we are looking for a

Senior Specialist Quality Assurance (m/f/d)

in a permanent and full time position.

Responsibilities

• Coordinate and actively support virtual and on-site audits and inspections
• Site Coordinator of external audits and self-inspections (internal audits)
• Coordinate CAPAs from audits and inspections
• Conduct supplier audits as external auditor, as well as self-inspections as lead auditor
• Perform quality review and approval of SOPs amd Supply Chain Changes as part of the Supplier Management process
• Perform quality review and approval of change controls, as well as supplier qualification as described in respective procedures
• Official back up of the Head of Quality Assurance Systems
• Lead and perform quality process improvements with independent analysis and optimization of quality processes regarding compliance, effectiveness, and efficiency in coordination with the employees responsible for the process or system

Profile

• BSc Degree or MSc Degree or equivalent degree with relevant experience in a scientific field preferred
• Minimum 7 years of professional experience in a pharmaceutical company, equivalent may be considered
• Experience in GMP audit management, preferably with authorities’ inspection experience (FDA, EMA, Health Canada…)
• GMP CFR Part 211, Eudralex volume 4 knowledge required
• Experience in project management as project manager required
• Experience as an external auditor preferred
• Fluent German and English
• Strong team work ethic and sound organizational skills for functioning with a high degree of independence on projects with minimal supervision
• Lean certification is a plus

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Our Support Functions deliver services and make recommendations about ways to enhance our workplace and the culture of our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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