Beschreibung
Task:- Lead the execution of the site gap assessment for combination products (i.e. coated threads)
- Lead, along with the project Quality Engineer, the implementation of the site action plan to comply with the combination products regulation
- Lead the execution of quality systems requirements during the implementation of the action plan, including but not limited to the internal audit program, document management process, document reading process and records management, using global software applications and Excel
- Execute internal and site criss cross audits to relevant, Franchise, Enterprise and Regulatory Standards:
- Provide training and support to site partners to ensure the successful and timely completion of implementation activities
- Provide Subject Matter Expert support during audits as applicable.
- Provide Quality subsystem process performance measurements to Quality and Operations Management as required
- Provide periodic updates of the implementation to senior management.
- Work effectively with other Quality and Operations associates to ensure consistent and compliant Quality subsystems
- Work effectively within the regional compliance team, and the sector compliance team, to ensure consistent/effective project deliverables
Requirements (Must have):
- Knowledge of Quality Systems Standards (BS EN ISO13485; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC)
- GMP knowledge requested!
- Important to have knowledge of Quality Systems standards for Pharmaceutical!! or Biological products
- Knowledge of equipment and test method validation processes essential.
- Knowledge in database administration and data manipulation for analysis and reporting purposes
- Desirable to have a degree in Life Science, Physical Science, Engineering or equivalent
- Desirable to hold a recognised Internal/Lead Auditor Certification and/or extensive or experience in executing audits, people with experiences in internal audits preferred!
- fluency in english and german
Beginn: 16.02.2015 bzw. ASAP
Dauer: 31.01.2016
Branche: Medizin/Healthcare