Amgen Jobshttp://www.amgen.jobs2012-05-26 21:00:45.783519NLDBredaAuto req 13960BR Job Posting Title Specialist QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objectives Provides the QA oversight review and approval of validation strategies and documents Provides QA oversight review and approval of Packaging Engineering strategies and documents Position Specific Tasks Operational - Provide guidance for validation impact assessment for change control requests. Participate in ABR projects and improvement efforts. - Ensures that Quality policies, procedures and programs are properly implemented in daily Process Development operations and remain in compliance - Provide coaching, guidance and compliance direction to Facilities, Engineering , Maintenance and Process Development. - Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications. - Develop solutions to complex validation problems requiring the use of ingenuity and creativity while maintaining compliant. - Work with project managers to complete the validation responsibilities of projects within schedule, budget and quality constraints. - Provide Quality oversight and approval for process development, engineering, validation projects and validation deliverables - Provide Quality oversight for good engineering practice documentation and system development. Process Maintenance: - Ensure Validation process at the site is maintained according to Corporate and GMP requirements and procedures reflecting process are in place and effective. - Integrate advanced validation engineering techniques ensuring alignment with industry standards. - Develop and provide Validation Training - Act as Validation contact in corporate and regulatory inspections, as needed. Basic Qualifications Minimum Requirements - Bachelor’s degree in Life Sciences or Engineering field or equivalent. - Typically 5+ years of related professional experience. OR - Master’s degree in Life Sciences or Engineering field or equivalent. - Typically 3+ years of related professional experience. OR - PhD in Life Sciences or Engineering field or equivalent. - Typically 1+ years of related professional experience. - Fluent in English. - Direct experience with regulated environment required. - Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, CFR 11, 210 and 211. Preferred Qualifications Preferred Requirements - Typically 10+ years of related industry experience in anufacturing and/or Quality Assurance. Strong knowledge of Good Distribution Practices.2012-02-16 21:59:39NetherlandsAmgenNone13960BRNoneBreda, NLD26576301http://www.amgen.jobs/xml/26576301/job