Amgen Jobshttp://www.amgen.jobs2012-05-26 14:39:28.044184NLDBredaAuto req 15730BR Job Posting Title Sr Associate QA Career Category Quality Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description Objective - To provide QA guidance and support in the production area at Amgen Breda - To perform batch record review of batches assembled, packaged and labeled and contract manufacturers. - To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person Position Specific tasks: - Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. - Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. - Review and approve batch production record data entries before production activities take place - Perform finished product checks during (commercial) production runs - Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person. - Act as author for operational SOP’s and Work Instructions - Review of operational SOP’s and Work Instructions - Review and approve class I Non Conformances - Initiate and own QA Non Conformances as needed. In this job you work in 3 shifts (including night shifts) Basic Qualifications - MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. - Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations. - Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. - Manufacturing and/or Quality analytical processes and operations. - Fluent in English language. Preferred Qualifications - Fluent in Dutch language2012-05-22 19:48:28NetherlandsAmgenNone15730BRNoneBreda, NLD28868677http://www.amgen.jobs/xml/28868677/jobNLDBredaAuto req 15718BR Job Posting Title Clinical Operations Manager Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Field Based Amgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification and site selection Strategically plans and coordinates Amgen sponsored trials (forecasting, resourcing, timelines, baseline recruitment) Adapt ICF to local requirements Defines study specific processes including study communication plans Ensures all study staff understand study deliverables and timelines Tracks local trial implementation, data collection and study reporting Reviews and approves monitoring reports and Site Initiation Packages (SIPs) Responsible with Medical staff for vendor selection and performance evaluation for local studies, including HE studies (services other than FSP) Provides regular updates on study progress to DOM and study sponsors as required, identifying barriers to site activation and patient enrollment and identifying potential solutions Ensures quality of study execution Escalates study-related issues Provides Amgen presence at investigator meetings / key visits Coordinate & actively participate at local investigators meetings Review GCA Site audit reports and work in conjunction with FSP staff and Site staff as required to fix issues Key interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up Project manages local clinical study teams Coordinates SACOM tasks, according to the COM-SACOM RASCI, when those are allocated to support COMs in the oversight of operational activities related to planning, executing and reporting of phase 3 / 4 studies Single point of contact at a project level for LOC staff and GSM Partners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs) Identifies and highlights risk areas (concerning operational readiness, communication and management) Ensures CRA receives necessary TA-related and study-related training Coordinates local study-related administrative tasks e.g. information to finance, status update to BU, status updates in local meetings Actively participates in the regional COM network as required Participate in the hub or country level Functional Management Team (FMT Governance) Basic Qualifications BA/BS/BSC or qualified nurse (RN) work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company or other relevant clinical setting) Preferred Qualifications Broad work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company Clinical trial management experience Operational performance measurement experience International collaboration experience2012-05-21 18:11:05NetherlandsAmgenNone15718BRNoneBreda, NLD28832994http://www.amgen.jobs/xml/28832994/jobNLDBredaAuto req 15370BR Job Posting Title Regional Medical Liaison Career Category Sales & Marketing Operations Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Field Based Amgen Job Description Key Activities - Supports Head Regional Medical Liason (RML)/local Therapeutic Area (TA) Leader in developing local territory R&D tactics - Identifies, develops and maintains collaborative relationships with current and future Key Opinion Leaders (KOLs), scientific experts, cooperative study groups and study sites - Develops and implements local KOL Plans, in line with local and international KOL strategy - Creates end execute engagement plans - Implements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals - Identifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research - Works with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories - Supports ASTs on site with scientific presentations/discussions to create enthusiasm for the scientific program, understand trial/referral networks and identify enrollment barriers, participates in investigator meetings according to approved investigator strategy - Represents Amgen Medical department in the territory - Ensures society engagement: RML support of international and regional congresses - Develops required qualitative and quantitative reports; collates competitor information - Ensures conduct of work in line with compliance regulations - Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments) Reports (at a minimum) to: Local Head RML or local TA Lead Responsible for: - Execution of RML Plan Of Actions - Scientific relationships in a set territory - KOL profiles, plans and reports - Engagement plans - Protocol proposals and other study documents for local ISSs - Territory input for feasibility and site selection - Scientific study site support for ASTs - Educational programs to change medical practice - Scientific presentations to physicians and hospital departments - Field feedback: scientific trends, ongoing studies, CI - RML activity tracking PLEASE NOTE: An Amgen year contract is offered for this position Basic Qualifications - Medical or scientific education or experience from similar positions - Minimum 3 years of experience in industry, or a related scientific field in academia - Experience in sales force, affiliate Medical Department or Clinical Development - Willingness to travel; possesses valid driver’s license - Experience with clinical study management and conduct - Scientific expertise in the therapeutic area - Knowledge of commercialization and business practices - Knowledge of regulatory affairs, drug safety, legal and compliance environment - Network of customer contacts - Medical / scientific research experience - Fluency in English and Dutch language is required for this role Preferred Qualifications - Advanced degree (e.g. PhD , MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training2012-04-19 20:55:12NetherlandsAmgenNone15370BRNoneBreda, NLD28013663http://www.amgen.jobs/xml/28013663/jobNLDBredaAuto req 14343BR Job Posting Title IS Business Analyst Employee Subgroup Salaried FT Country (State/Region) The Netherlands Location (City) Breda Amgen Job Description The Information System (IS) Business Analyst is a functional analyst with client facing and supply responsibilities. This role will ensure a successful IS implementation by evaluating the principal business needs, challenging technical solutions and facilitating the change process. The person taking this role will be responsible for International OTC processes within a global context. This role will work in close coordination with other members of the Operations and SAP Center of Excellence teams in Europe and US. The Business Analyst will participate in gathering requirements, design development and the review of SAP Configuration. Primary Focus/ General Accountability: ? This role is responsible for leading and developing the further implementation of OTC processes (both SAP & non-SAP). This could involve working within the EDI space, so knowledge of this along with other interfaces to external 3rd parties is critical. ? Ongoing maintenance and configuration activities related to this space ? Lead the development, configuration and system integration for the implementation of OTC processes in a global environment. ? Act as in-house OTC subject matter expert and support ongoing activities. ? Provide 3rd level support for SAP OTC/BAR users. ? Lead / Participate in OTC change requests and projects. ? Analyze functional requirements and drive the development of detailed functional / configuration / systems specifications and documentation. ? Responsible for completeness and quality of functional design. ? Provide high-level estimates for design and implementation effort. Basic Qualifications ? Minimum 3+ years hands on experience in the SAP OTC implementation and configuration, specific knowledge on SD and other products within this space (XPI, iDocs and Xi). ? Must have a strong working knowledge of SAP SD ? Experience in global operating SAP OTC implementations. ? Experience in Business Process Analysis & Design to make the connection between SAP and 3rd parties’ distribution systems. ? Experience in testing and production delivery. ? Experienced in functional and technical specification development. ? Experienced in troubleshooting and resolving SAP functional problems. ? Understanding of complex interfaces between different SAP systems. ? Bachelor or Master degree, preferably in Commerce/Business, Engineering or Computer Science. ? Strong analytical skills. ? Strong teamwork skills. ? Strong written and oral communication skills. ? Experience working in a regulated industry (Biotech or Pharmaceutical Industry preferred). Preferred Qualifications Knowledge - Knowledge of computer validation concepts in compliance with FDA/EMEA and other regulatory requirements. Experience - Systems Design Analysis - Network Technologies - Web Technologies - Computer Systems and Security2012-03-22 18:52:24NetherlandsAmgenNone14343BRNoneBreda, NLD27320715http://www.amgen.jobs/xml/27320715/jobNLDBredaAuto 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