Steril Release Coordinator
Nyírbátor, HU
Your primary tasks/responsibilities:
- responsible for the release of sterile products,
- analysing if products are in compliance with specifications,
- manage and maintain the NCRs at all stages of steril release process; make root cause analyses implement and document actions,
- coordinate the daily work of sterile-release team,
- adjusting data according information from forwarder, warehouses and sterilization plants,
- updating relevant instructions and specifications used in the department,
- support the global sterilization team in case revision of new or updated procedures, instruction;
- performing different stability tests, together with Sterile Release leader coordinate the works from test phase until data uploading,
- 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 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, Coloplast used programs),
- able to keep deadlines,
- have structured thinking.
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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