Global Auditor Europe and Middle East Job

Date: Apr 5, 2019

Location: Haarlem, NH, NL

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Requisition ID: QUA008437

Did you always want to work in a company where your work can have a real impact on people’s life? Do you enjoy working in an international environment with lots of room for personal development?


We have an exciting opportunity for an Global Auditor Europe and Middle East


The person in this role 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 the company’s requirements and applicable global regulations.


Responsibilities
• 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 time frames. 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.


Education
Bachelor’s Degree in Pharmacy, Chemistry, (Micro-) Biology, Chemical Engineering (or equivalent).
Qualifications

Your profile



                   
Minimum of
8 years of manufacturing, technology, and/or quality operation experience
within an EU/FDA, API, Drug Product, Medical Device or equivalent environment.



                   
Quality/compliance
experience in an EU/FDA regulated industry.



                   
Experience
performing audits of external and internal manufacturers and testing
laboratories.



                   
Thorough
understanding of Quality Management Systems and process to support the
manufacturing of API’s, drugs products, and medical devices, including risk
management.



                   
Strong
compliance knowledge and proficiency in interpreting and applying regulatory
requirements and guidelines.



                   
Ability to
work independently with limited supervision in a virtual-management
environment.



                   
Must
possess “Subject Matter Expertise”, including knowledge and demonstrated
application in one or more of the following areas; Medical Device/Combination
product, Biologics, Vaccines, API’s, Non-sterile Drug Product or Sterile Drug
Product manufacture.



                   
Excellent/accomplished
communication, negotiation, facilitation, influencing, and strategic thinking
skills at all levels of organization



                   
Must have
the ability to travel globally approximately 50% of the time.



 



Preferred



                   
External
engagement in regulatory or industry forums.



                   
Current
with regulatory expectations and requirements.



                   
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.



                   
Experience
with direct participation on interdisciplinary Due Diligence teams – with
Senior Management, inclusive of initial risk/compliance assessment based on
documentation.



                   
Lean
six-sigma belt / demonstrated process improvement experience.



                   
Knowledge
and expertise in application of Quality Risk Management pertaining to auditing,
above-site function/processes, or technical areas.



                   
Knowledge
of Quality by Design development & submission requirements



                   
Experience
with development, implementation and optimization of IT tools to deliver
business outcomes/impact.



 



About us



MSD is a global health
care leader with a diversified portfolio of prescription medicines, vaccines
and animal health products. The difference between potential and achievement
lies in the spark that fuels innovation and inventiveness; this is the space
where MSD has codified its 125-year legacy. MSD’s success is backed by ethical
integrity, forward momentum, and an inspiring mission to achieve new milestones
in global healthcare.



 



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.
 






Job: Quality Operations
Other Locations: BE; LV; Estonia; LT; PL; PT; HR; CZ; DK; NO; SE; FI; AT; DE; GB; CH; ES; IT
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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