Beschreibung
Task:• Lead the review of the site gap assessment for combination products
• Lead, along with the project Quality Engineer, the implementation of the sites action plan and Quality 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 ETQ, Adaptiv, Compliance Wire 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 SME support during Notified Body, Competent Authority, Franchise, Customer and Internal Audits
• Provide Quality subsystem process performance measurements to Quality and Operations Management as required
• Provide periodic updates of the implementation to senior management during Quality Review Boards.
• Work effectively with other Quality and Operations associates to ensure consistent and compliant Quality subsystems
• Work effectively within the EMEA compliance team, and the MD compliance team, to ensure consistent/effective project deliverables
Requirements (Must have):
• Experiences in a similar Compliance Position is essential!
• Knowledge of Quality Systems Standards (BS EN ISO13485; FDA Medical Devices Quality Systems Regulation 21 CFR 820; Medical Device Directive 93/42/EEC, 21 CFR Part 211, 21 CFR Part 4)
• Highly desirable 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
• Very good verbal and written communication skills in English is a MUST
• Although not essential, German language skills would be an advantage
• Good team working ethos
Environment/Miscellaneous:
• This position will be located either at Norderstedt (Schleswig-Holstein, Germany) or Kirkton (Livingston, Scotland) and will require approx. 25% travel to the alternate location
Beginn: 01.02.2016
Dauer: 31.12.2016
Branche: Medizin/Healthcare