Organon - Senior Auditor Quality Compliance
Molenstraat, Oss, Netherlands
2 dagen geleden

Job Description

Do you have an academic degree or similar level by working (Pharmacy, Life Sciences or equivalent) and at least 7 years of experience in the Pharmaceutical industry, of which preferably 3-5 years in Quality Assurance / Systems, or related field?

Do you have experience with auditing and Health Authority inspections and a proven compliance mindset? Do you want to work for a site with a large diversity of products and production processes?

Do you have the potential and ambition to grow to a managerial role within a few years?

For our Quality Operations organization within Pharmaceutical Operations in Oss we are currently hiring a :

Senior Auditor Quality Compliance

Purpose of the role

Reporting into the Site Lead Auditor you will be responsible to provide an independent Quality oversight over all GMP related activities across Pharm Ops to ensure compliance with cGMP, regulatory and applicable QMS requirements.

You will be responsible for the preparation of the annual audit plan based on quality risk principles and for the preparation of the annual audit evaluation report and making proposals for improvement.

We are explicitly looking for someone with ambition and growth potential, able to develop to managerial roles within a few years.

Welcome in our team

Quality Operations Pharm Ops (Pharmaceutical Operations) (around 200 people) is responsible for ensuring that our Manufacturing Division in Oss manufactures, tests and releases Drug Products, Medical Devices and Combination Products in accordance to applicable local and international regulations.

To this end the various Quality departments actively collaborate and set standards for all Integrated Process Teams (IPTs) and CoEs (Centers of Excellence) of our Manufacturing Division as well as regularly interact with other manufacturing sites.

In Pharmaceutical Operations Oss we have a large diversity of pharmaceutical and medical device products and production processes, with in-house laboratory facilities and warehousing.

Main responsibilities

  • Performing and reporting System Audits and Walk-Through Audits at the various Integrated Process Teams (IPT) and Center of Excellences (CoE);
  • Assessment of responses, including root causes, and corrective and preventive action (CAPA) plans and assessment of correct implementation of these actions;
  • Supporting government inspections, notified body audits and customer audits, both in preparation, front office, back office and preparation room;
  • Provide support in coordinating the responses (CAPAs) formulated by Pharm Ops Oss to the observations made by governments, customers and notified bodies;
  • Monitoring the implementation of CAPAs following government inspections, notified body audits and customer audits;
  • Participation in the Auditor Community or Practice;
  • Performing audits at other sites of the company in collaboration with Global auditing (Guest Auditor Program);
  • Preparation and generation of metrics for audits, inspections and CAPAs and making improvement proposals;
  • Subsystem owner for subsystem Auditing;
  • Collaboration with Global auditing, Global Compliance and Remediation Support and company Auditors.

    Your profile

  • Academic Degree or similar level by working (Pharmacy, Life Sciences or equivalent);
  • At least 7 years of experience in the Pharmaceutical industry, of which preferably 3-5 years in Quality Assurance / Systems or related field;
  • Experience with auditing and Health Authority inspections;
  • Knowledge of quality management systems, GMP, and / or other relevant regulations and ISO standards;
  • Proven compliance mindset;
  • Demonstrated ability to manage complexity and handle / prioritize multiple tasks;
  • Convincing, critical, accurate, flexible;
  • Excellent written and verbal communication skills in Dutch and English;
  • Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.

    We offer

    We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development.

    Our benefits are very competitive and the summary below will give you an idea of what you can expect.

  • Competitive salary and a 3% year-end bonus;
  • 35,5 days of leave;
  • Attractive collective health care insurance package with considerable reduction rates;
  • Solid Pension Plan;
  • Incentive Plan;
  • Travel allowance for commuting;
  • Numerous training, coaching and e-learning modules for long term job opportunities and development.

    For questions about this vacancy, please send an email including the vacancy number and job title to the following email address :

    Applications can only be submitted via our website.

    Who we are

    We are known as Merck & Co., Inc., Kenilworth, 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.

    We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers.

    We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

    In The Netherlands we have 6.000 colleagues on 4 different locations, i.e. Haarlem, De Bilt, Oss and Boxmeer.

    What we look for

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come.

    We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.


    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 for the common good.

    We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    Search Firm Representatives Please Read Carefully

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.

    Employee Status : Regular

    Relocation : Domestic

    VISA Sponsorship :

    Travel Requirements :

    Flexible Work Arrangements :

    Shift :

    Valid Driving License :

    Hazardous Material(s) :

    deze vacature melden

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Mijn E-mail
    Door op "Doorgaan" te klikken, betekent dit dat je neuvoo toestemming geeft om je gegevens te verwerken en je e-mails met vacatures te sturen, zoals beschreven in neuvoo's -Privacybeleid . Je kunt je toestemming altijd intrekken