Description
Compliance Engineer 12 Months to £32 Livingston - Hamburg 25% travel
Project is combination products a pharma product need a Compliance person to oversee all activities - completing tasks on target and to regulations etc. Up to 25% travel to other site - planned and scheduled trip to make use of the travel. Fluent in German and English would be ideal. Medical Devices and pharmaceutical or combination products exp ideally. This is not a Junior role or a Consultant level role. Looking for something in between We have an exciting opportunity for an experienced Compliance Engineer reporting to the site Compliance Manager. The successful candidate will support the site gap assessment and implementation plans for combination products regulatory requirements for an initial period of 12 months.
Principal Duties and Responsibilities
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
Skills Required
Required Education, Training and/or Experience
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 hold a recognised Internal/Lead Auditor
Certification and/or extensive or experience in executing audits
Good verbal and written communication skills in English is essential Although not essential, German language skills would be an advantage
Good team working ethos
Qualifications Required
Desirable to have a degree in Life Science, Physical Science, Engineering or equivalent