Senior Auditor
MSD
Molenstraat, Oss, Netherlands
5 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 Quality Assurance / Systems, Pharmaceutcial Production or related field?

Do you have experience with auditing and Health Authority inspections and a proven compliance mindset?

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

Welcome to our team

Quality Operations Pharm Ops (Pharmaceutical Operations) (around 200 people) is responsible for ensuring that our Manufacturing Division 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 Oss as well as regularly interact with other sites.

Reporting into the Site Lead Auditor the Senior Auditor is 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.

Primary responsibilities

  • Preparation of the annual audit plan based on quality risk principles;
  • Preparation of the annual audit evaluation report and making proposals for improvement;
  • Performing and reporting System Audits and Walk-Through Audits at the various Integrated Process Teams (IPT) and Center of Excellences (CoE);
  • Assessment of corrective and preventive actions (CAPAs) including Root Cause Analyzes and follow-up of correct implementation of these actions in consultation with the auditee;
  • 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 company’s sites, contractors or suppliers in collaboration with divisional auditing (Guest Auditor Program);
  • Preparation and generation of metrics for audits, inspections and CAPAs and making improvement proposals;
  • Subsytem owner for subsystem Auditing;
  • Collaboration with, divisional auditing, Global Compliance and Remediation Support and company’s Auditors.
  • Qualifications

  • Academic Degree or similar level by working (Pharmacy, Life Sciences or equivalent);
  • At least 7 years of experience in Quality Assurance / Systems, Pharmaceutcial Production 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.
  • Who we are

    Merck & Co., Inc., Kenilworth, New Jersey, USA is known as Merck in the United States, Canada & Puerto Rico. We are known as MSD in Europe, Middle East, Africa, Latin America & Asia Pacific.

    We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

    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.

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