Qualified Person/ QP – Animal Health Job

Date: Apr 16, 2019

Location: Boxmeer, NB, NL

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Requisition ID: QUA008563

Do you enjoy working in an international environment with lots of room for personnel development?



 


At MSD Animal Health we have an exciting opportunity for a:


Qualified Person/ QP



 


As a qualified person at MSD Animal Health you ensure that products are manufactured according to guidelines and regulations. Based on that assessment, you are responsible for the release and certification of finished products for supply to the market.



 



It is the policy of MSD Animal Health, Boxmeer, that each batch of finished product, packed or unpacked, must be certified by a QP within the EU/EEA before being released for sale or supply in the EU/EEA or for export. The QP has to ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorization, the principles and guidelines of EU Good Manufacturing Practice or the good manufacturing practice of a third country recognized as equivalent under a mutual recognition agreement and any other relevant legal requirement before it is placed on the market.



 



The Qualified Person is a position within the Quality Assurance function of the Quality Operations division of MSD Animal Health, Boxmeer. Quality Assurance is comprised of several departments designed to oversee manufacturing activities in accordance with current Good Manufacturing Practices (cGMP), namely, cradle-to-grave responsibility for manufacturing, receipt, storage, testing, processing, packaging, release, holding, labeling and distribution activities.



 


The QP will be positioned within the QA-IPT live department, which is responsible for the quality oversight of the manufacturing of live vaccines. The QP directly reports into the Departmental Manager.


 


 



Responsibilities




  • Ensure that product is manufactured in compliance with regulations and guidelines


  • Ensure that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date


  • Decide on release and/or certification of finished product


  • Document decisions regarding product release/certification


  • Support root cause analysis in case of deviations with potential impact on product efficacy, safety or compliance


  • Approve root cause investigations and associated conclusions and corrective and preventive actions


  • Review and approve change proposals and periodic product quality review reports


  • Prepare management notifications in case of significant quality issues


  • Prepare or review Fact finding meeting presentations


  • Participate in external supplier audits as auditor


  • Acts as Sub System Owner on system level and is a representative for the assigned Quality System


  • Support health authority inspections
Qualifications

Desired skills & experience




  • Master’s degree in Pharmacy or equivalent academic study (meeting requirements as specified in EU-GMP directive 2001/83/EC)


  • At least two years of experience as a Qualified Person/ QP  in the pharmaceutical or medical device industry


  • Extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and non-routine cases


  • Excellent oral and written communication skills in Dutch and English


 



What 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


  • MSD Incentive Plan


  • Travel allowance for commuting




  • Numerous training, coaching and e-learning modules for long term job opportunities and development


Information
For further information regarding this position, please contact Judith Tiggelers – Jetten, Associate Director Quality, via 0485 – 585542.



 



Application
If you are interested in this challenging role, you are requested to apply online by uploading your resume and application letter in English.


 


 



About us
MSD Animal Health is a research-driven company that develops, manufactures and markets a broad range of veterinary medicines and services. We offer one of the industry’s most innovative portfolios, spanning products for the prevention, treatment and control of disease in all major farm and companion animal species.




We are a highly proactive, robust and diversified company with a strong, scientifically-proven, product portfolio and an ever-growing reach. With offices in more than 50 countries, we successfully market
our products in more than 140 countries and operate a network of manufacturing sites and research and development (R&D) facilities around the world.


 



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Animal Health, Pharmacy, Pharmaceutical, Supply, Healthcare, Veterinary, Science, Operations

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