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Quality
Would you like to join an award-winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Position Summary
The Environmental Monitoring Supervisor leads the Environmental Monitoring (EM) team and works closely with other departments, such as Operations, Maintenance, Quality Assurance, and Engineering to assure the support of the Environmental Monitoring department on various projects, studies and routine tasks.
The individual holding the position of Aseptic Environmental Supervisor shall be responsible for coordinating the timely completion of routine and project testing. This person will also be responsible for coordinating actions associated with environmental issues. They will assist with the training of EM, Production and Quality Assurance personnel in environmental monitoring tests and methods.
Key Responsibilities
- Investigates and resolves Environmental Excursion investigations.
- Prepares and executes protocols for performance qualifications and requalification’s.
- Supervises the day-to-day activities of the EM team.
- Evaluation and monitoring of personnel for Aseptic Behavior.
- Compiles and analyzes data for quality metrics.
- Development and revision of standard operating procedures (SOPs).
- Trains new department personnel and personnel of other departments on SOPs relative to environmental monitoring.
- Provides validation test support.
- Performs environmental monitoring and the collection of utility samples.
- Performs evaluation of the classified areas with regards to fit and finish.
- Assists with the execution of equipment and method validation.
- Reviews data generated by EM technicians and approves testing paperwork.
- Assists in compiling data for Annual Reports.
- Coordinate and lead the training of EM and production personnel on proper aseptic technique, behaviors, setup and operation of equipment. Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
- Schedules EM Techs to assure support of operations activities.
- Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Experience and Skills
- Bachelor’s Degree in Microbiology/Science based curricula or five plus years related experience.
- Ability to understand, and work with, regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Experience in the pharmaceutical industry in regards to Aseptic/Injectable processes desirable.
- Strong leadership skills required.
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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.8.2020, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
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