Manufacturing Quality Assurance Supervisor - Night Shift (12 Hrs) 1
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Quality
Position Summary
The Manufacturing Quality Assurance (MQA) Supervisor is responsible for daily management of quality assurance operations at the Xellia Cleveland site. The MQA Supervisor will manage the daily tasks for the applicable shift to support the manufacturing operation. The areas of responsibility for the MQA Supervisor are: On the floor Quality oversight, batch record review, logbook review, review and approval of work orders and identification of deviations. This includes collaboration, development, implementation and management of quality assurance processes, procedures and best practices.
Key Responsibilities
- Supervise, develop, manage and train personnel in MQA
- Quality Oversight of the manufacturing areas including batch record review, logbook review, general condition of the controlled areas and monitoring of cleanroom behaviors
- Responsible for personnel management including hiring, development and performance management
- Quality Oversight for the calibration and maintenance system
- Responsible for the authorization of SOP’s and/or qualification/validation documents
- Assist with deviations including scope, impact and associated corrective actions
- Participation in Change Control committee, evaluation and authorization of change controls
- Ensure that direct reports are current on all required training
- Collecting and reporting data for the monthly Site Governance Meeting
- Perform additional tasks in relation to quality issues as agreed with the MQA Manager
- Manage and escalate Quality issues to the MQA Manager
Requirements
- B.S. in Physical Science or Engineering or 3+ years of relevant experience
- A good knowledge of various GMP compliances regulations and industry practices Ability to critically evaluate and troubleshoot complex problems is essential
- Ability to effectively participate on multi-disciplinary teams
- Ability to absorb, digest and relate detailed scientific, quality, and regulatory information
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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