Packaging and Inspection Supervisor - Night Shift
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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 a Packaging and Inspection Supervisor to oversee packaging of sterile products so that both product and production are in cGMP compliance. Establish systems that support procedures to continuously improve and heighten performance and quality. Ensure adherence to the production plan and delivery of On Time In Full targets by having stable processes with minimal variation. Develop production operator competencies in a coaching, empathetic and trusting manner. Train production operators in all departmental procedures. Understand site SOP’s and cGMPs relative to the positions within your team and ensure compliance with these standards.
Key Responsibilities
- Make sure that the daily production is running optimally in assigned area, both in terms of output and quality.
- Establish framework and daily structure in which the production operators are able to conduct production in an efficient manner. Support and continually develop positive culture with direct and indirect team, aligned with company values
- Ensure that current requirements to environment, safety and health issues are met within the production.
- Take initiative and make decisions with a short response time as lack of or late decisions could result in missing an order.
- Ensure that systematic problem solving happens on the shop floor where all relevant stakeholders are involved.
- Include relevant stakeholders in decision-making in regards to planning production and other daily operations.
- Make certain that equipment is maintained correctly according to the overall plan in line with current pharmaceutical regulatory requirement, industry standards, government regulations, budgetary agreements, and requirements as appropriate.
- Develop and implement written departmental procedures.
- May participate as SME in regulatory audits, i.e. FDA, EMA, and others.
- Set up and monitor training plan to ensure production flexibility 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.
Requirements
- Bachelor’s degree in Engineering or in Natural Science preferred or other relevant education
- 3 years of prior leadership experience with production processes. Packaging, Inspection, or sterile bag manufacturing experience preferred
- Strong people development skills
- Knowledge of GMP and a quality mind-set
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.
- Lagermedarbejder
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