Steril Release Coordinator

Your tasks/responsibilities:

• responsible for the accurate and on time release of sterile finished goods,
• analysing if products are in compliance with specifications,
• manage and maintain the NCRs at all stages of sterile release process; make root cause analyses implement and document actions,
• adjusting data according to information from forwarder, warehouses and sterilization plants,
• clear and on time communication related to sterile release process to the stakeholders (like production sites; distribution centres; sterilization sites; local supply chain)
• participation in coordination meetings, where represents NYI site and the compliance of the sterile release process
• updating relevant instructions and specifications used in the department,
• support the global sterilization team in case revision of new or updated procedures, instruction
• performing and organize the performing of different stability tests
• organize and follow up the stability activity at NYI site, contact with stability study owners and local stakeholders (like facility, production, shipping)
• document and archive activities,
• one-point-of-contact in case quarantine of finish goods
• responsible for written and verbal communication quality related issues to key stakeholders,
• responsible for follow-up on quality related issues all along the sterile release processes,
• prepare reports to stakeholders,
• represent the sterile release team during internal and external audits;
• daily - written and verbal - contact with Coloplast sites at Denmark and China; and sterilization plants in Denmark, Germany, Austria, Belgium about quality related issues,
• daily contact with all relevant local department and support functions at headquarter in Denmark.

Your qualifications:

• college or university degree,
• experience in sterile release processes or in similar fields,
• excellent written and verbal communication skills in English,
• very good user knowledge of computer (MS Office, E1),
• able to keep deadlines,
• have structured thinking
• team player and able to coordinate the daily work

Advantage:

• experience in field of quality assurance or sterile release areas in medical device industry

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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