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Production
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!
Our Bedford, OH facility is seeking Responsible for execution of all aspects of packaging operations which includes, but is not limited to, the secondary packaging line, labelling, and equipment cleaning. Interacts with Quality, Technical Services, Maintenance, Warehouse Departments, and other departments as required.
Ensures that daily production is carried out according to current SOP’s ensuring absolute compliance to quality standards. The Operator is responsible for documenting daily production outputs and efficiencies and keeps other stakeholders involved and informed. Challenges on the line are documented and resolved by means of various LEAN tools. Collaborates in the training of colleagues.
Key Responsibilities
- Ensure packaging lines are running smoothly, within validated parameters, and in compliance with cGMP’s. Ensure packaging process is carried out and documented within a high level of compliance.
- Performs line change overs and simple-to-moderate equipment adjustments.
- Supports the creation and updating of procedures enabling the improvement of quality, compliance, and overall process performance.
- React to issues on the line and start up systematic problem solving enabling colleagues to support root cause analysis.
- Adhere to cGMP’s, SOP’s, Batch Record processing steps, and site environmental and safety policies.
- Support a continuous improvement culture and mind set within the department by proposing optimizations.
- Possess strong commitment to quality and compliance. Guide colleagues in the importance of proactive behavior in regards to improving the work environment towards zero accidents.
- Work closely together with quality to solve quality issues as they occur and ensure timely release of products.
- Communicate challenges and successes openly and honestly to all employees in the team.
- 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 Parts 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
- High School Education or GED
- Associates Degree in a natural science or technical curriculum preferred; Pharmaceutical or medical device manufacturing experience preferred
- Prior experience with complex high speed packaging equipment
- Good technical experience with quality control technology including vision, robots or automation preferred
- Knowledge of cGMP requirements preferred
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 "Lagermedarbejder", og befinder sig i kategorien "Industri, håndværk og teknik".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
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