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Quality Assurance Auditor - GMP (home based in Europe) Job
MSD | Lu Verne, Iowa
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Job Description

Quality Assurance Auditor - GMP (home based in Europe)-QUA005402


MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Quality Assurance Auditor - GMP (Senior Specialist, Quality Assurance & Compliance - GMP).

There is flexibility for this person to work remote / from home and to be based in European locations such as; The Netherlands (Haarlem, Oss, Boxmeer), Belgium (Heist), UK (Hoddesdon, Cramlington, Milton Keynes, Harefield ), Germany (Fresioythe, Unterschleissheim, Cologne, Burgwedel), Austria (Vienna), France (Clermont Ferrand, Igoville, Hérouville Saint Clair, Segre), Ireland (Dublin, Carlow, Brinny, Clonmel), Switzerland (Werthenstein), Italy (Aprilla), Spain (Madrid, Salamanca)as they will be required to travel 50% of the time.

The position is primarily responsible for executing and leading internal and external GMP audits following MSD's auditing policy and guidance to ensure compliance with worldwide regulatory expectations. This includes ensuring that facilities and buildings, equipment, personnel, organization, methods, procedures, records, reports, and/or controls are in conformance with MSD requirements and applicable global regulations.

Responsible to achieve and maintain qualification / certification status through robust training and continuing education programs to enable conducting audits of Human Health, Animal Health and Consumer Care Sites, Contracted facilities, Distribution Centers, Business Partners and Suppliers. Responsible for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes. The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, GMP documentation as well as extensive communication and partnership with divisional oversight groups and commercial sites.

- Schedule and perform assigned audits and ensure timelines for audit steps (prework, conducting audit, issuance of audit report, CAPA receipt) meet established expectations. This requires approximately 50% worldwide travel.
- Review and approve audit reports.
- Maintain a broad based expertise of cGMP's, MSD Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Vaccines, Small Molecules, Combination Products, APIs and Controlled Substances.
- Obtain and maintain cutting-edge knowledge, application, and certification status for various technical/Quality auditing topics
- Maintain awareness of evolving industry and regulatory trends/regulations. Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre-Contract Audits, issuance of reports, and evaluation of corrective and preventive actions. Assist with preparation of annual audit schedule, using risk based approaches for auditor assignment
- Lead & Coordinate with Procurement and impacted Site Quality leads on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring required assessments are performed.
- Provide regulatory inspection support to MSD Sites as it relates to the Divisional Audit program, status of audits, and specific audit results.
- Provides support and administrative functions for the electronic Supplier Tracking and Repository System, and assists in data maintenance.
- Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations.
Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities and associated strategic/tactical thinking.


Education Minimum Requirement:
- Bachelor Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
- Minimum of 5 years of manufacturing, technology, and/or quality experience within an FDA, and/or EU API, Drug Product, Medical Device or equivalent environment.
- Experience performing audits of external and internal manufacturers and testing laboratories. Must have a working knowledge of processes to support the manufacturing of APIs and Drug Products.
- Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
- Ability to travel globally approximately 50% of the time.
- Ability to work independently with limited supervision in a virtual-management environment
- Excellent/accomplished communication, negotiation, and facilitation skills.
Preferred Experience and Skills:
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives
- Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas
- Lean six-sigma belt / demonstrated process improvement experience
- Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

Are you interested in contributing your know-how to a dynamic and innovative environment that allows you to show initiative and that offers long-term perspectives in an international environment?

Job: Quality GMP Related Job Title:Senior Specialist Quality and Compliance - GMP

Primary Location: EMEA-Switzerland-LU-Luzern

Other Locations: EMEA-Belgium, EMEA-Italy, EMEA-France, EMEA-Netherlands, EMEA-Germany, EMEA-Spain, EMEA-Ireland, EMEA-United Kingdom, EMEA-Austria, EMEA-Switzerland

Employee Status: Regular

Travel: Yes, 50 % of the Time

Number of Openings: 1

Company Trade Name:MSD

About MSD

MSD Ignition is a company built on Customer Satisfaction and Service. That is why all of our products go through regimented test procedures before they are ever packaged and shipped. MSD stands behind our products for one full year after purchase and we have an excellent repair department. Terms of Warranty and Service are as follows: Limited Warranty Autotronic Controls Corporation warrants MSD Ignition products to be free from defects in material and workmanship under normal use and if properly installed for a period of one year from date of purchase. If found to be defective as mentioned above, it will be replaced or repaired if returned prepaid along with proof of date of purchase. This shall constitute the sole remedy of the purchaser and the sole liability of Autotronic Controls Corporation to the extent permitted by law, the foregoing is exclusive and in lieu of all other warranties or representations whether expressed or implied, including any implied warranty of merchantability or fitness. In no event shall Autotronic Controls Corporation be liable for special or consequential damages. This warranty is only valid on products purchased from MSD Authorized Dealers.

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