Quality Assurance Officer - contract position
Posted on 08/06/16
Come join us
Position: Quality Assurance Officer
Location: Sandwich, Kent, UK
Contract: Contract position - 12 month duration
Company: Mylan Global Respiratory Group
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 seven 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.
The successful candidate will support MGRG QA group in the ongoing compliance and continuous improvement of the Quality Management System, underwriting the Manufacturing, Analytical and Materials Management areas and the external vendor oversight program.
Providing support to the QA group in the ongoing support of the Quality Management System, including:
To assist and support the development and maintenance of GxP documentation.
To assist in the development and maintenance of specific quality areas/systems with manufacturing, analytical, clinical supply chain and the science and technology development processes.
To assist in planned deviations and change controls, and lead investigations, ensuring GxP compliance is maintained.
To assist in the creation and maintenance of SOPs as required, ensuring alignment between business lines and MGRG sites, and compliance with current regulations.
To assist in the development and maintenance of training systems
To represent Quality Assurance in discussions and action plans for assigned projects
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 contribute to set new standards in healthcare. Here are the minimum qualifications and essential functions for this position:
Essential: * Demonstrable front line experience in pharmaceutical drug product QA/QO, OR manufacturing, OR drug product/analytical development, OR in a regulated environment.
Have a clear understanding of the principles of pharmaceutical GMP or Quality Management Systems
Be a clear communicator and able to reach clear reasoned solutions to problems/challenges
Be able to work and communicate with external vendors to create good working relationships and maintain quality oversight
Have an understanding of the challenges associated with QA work
Be a hardworking, reliable team player, who is proactive and has a strong track record of delivery
Have an understanding of formulation and analytical development
Have an understanding of device development
Experience in manufacture/testing operations for inhalation products
Experience in analytical, facility, equipment and cleaning validation
Experience of the review and approval of GMP documentation, including manufacturing and analytical documentation, and quality disposition of GMP materials
Experience in internal or external audits
Educated to degree level
If you want to be a part of a global healthcare company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 30,000 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 healthcare.
Mylan is an Equal Opportunity Employer.
Please note this role is a temporary position for an initial 12 month period.
To submit your application, please submit your CV/Covering letter to email@example.com - stating “Quality Assurance Officer - contract position” in the subject line.