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Mylan

Quality Assurance Executive III (Regional Quality)

Mylan

  • Galway
  • Not disclosed
  • Permanent full-time
  • Updated 03/01/2018
this job is expired
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Description

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and pass...

 

For Us, It's A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people. If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.
 
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here's how this role will help:

 

  • Support Annual Reports submission, Product Development and Product Launch for Mylan Injectable Affiliate Sites.

  • Review of stability data for Affiliate Injectable Sites. Support the Affiliate Sites in investigating laboratory OOSs.

  • Support of Investigation of product complaints, OOS and non-conformances of Affiliate Sites & Associated Vendors.

  • Support review of FARs/Recalls for US Injectable Affiliate sites.

  • Review of Product Quality Review Reports for Affiliate Injectable Sites.

  • Provide Technical Transfer and Process Validation Support.

  • Review equipment, process, method validation protocols and reports, and stability protocols and reports.

  • Review of Technical Agreements and Confidentiality Agreements.

  • Provide training to Regional QA staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures when required.

 

Make Our Values Your Values

Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:  

  • Minimum of a Bachelor's degree (or equivalent) in a life science or pharmacy and 5-8 years of experience in quality control or quality assurance within a pharmaceutical company. Experience of sterile injectable manufacturing and third party/affiliate site quality management desirable but not essential.
  • Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, and batch release.
  • Knowledge of Quality Control testing, Advanced knowledge of chemistry, previous HPLC experience (preferably with Empower software) is essential. Experience in troubleshooting within a QC laboratory background is desirable.
  • Knowledge of Validation and Aseptic manufacturing an advantage but not essential.
  • Knowledge of Pharmaceutical QMS Systems and of Quality Risk Management Systems.
  • Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.
  • Knowledge and experience in the use of Data Sharing Software Packages an advantage.
  • Periodic travel may be required.
  • Proficiency in speaking, comprehending, reading, and writing English is required.

Why Mylan?

If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

 

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer.

...

Ref: 17001532
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