Beschreibung
For a global acting pharmaceutical company I am currently looking for a Freelance Compliance Engineer.The successful candidate will support the site gap assessment and implementation plans for combination products regulatory requirements for an initial period of 11 months.
Principal Duties and Responsibilities
* Lead the review of the site gap assessment for combination products (Very important)
* Lead, along with the project Quality Engineer, the implementation of the sites action plan and Quality Plan to comply with the combination products regulation (Very important)
* 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 Required Education, Training and/or Experience
* Experiences in a similar Compliance Position is essential! (Very important)
* 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 (Very important)
* 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
Location
* 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
Additional Job/Position requirements
* Apply Credo values in an open and ethical manner and promote CREDO values within the compliance and site teams.
* Open, collaborative, interactive style
* Balanced decision-making
* Strong collaboration and influence management skills to partner effectively across functions
* Use facts and rational arguments to influence and persuade
Conditions
hourly rate: 68 €
start date: 01. February 2016
end date: 31. December 2016
utilization per week: 100% on-site or travels to England
If you are interested please contact me!
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