[{"country_short": "NLD", "city": "Breda", "description": "Auto req 15730BR\nJob Posting Title Sr Associate QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen Job Description Objective\n- To provide QA guidance and support in the production area at Amgen Breda\n- To perform batch record review of batches assembled, packaged and labeled and contract manufacturers.\n- To establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person\n\nPosition Specific tasks:\n- Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions.\n- Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.\n- Review and approve batch production record data entries before production activities take place\n- Perform finished product checks during (commercial) production runs\n- Compile and review batch records for lots assembled, packaged and labeled and contract manufacturers in preparation for disposition by Qualified Person.\n- Act as author for operational SOP\u2019s and Work Instructions\n- Review of operational SOP\u2019s and Work Instructions\n- Review and approve class I Non Conformances\n- Initiate and own QA Non Conformances as needed.\n\nIn this job you work in 3 shifts (including night shifts)\nBasic Qualifications - MBO or Bachelor\u2019s degree in Life Sciences or related field or the equivalent combination of education and/or experience.\n- 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.\n- 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.\n- Manufacturing and/or Quality analytical processes and operations.\n- Fluent in English language.\nPreferred Qualifications - Fluent in Dutch language", "date_new": "2012-05-22 19:48:28", "url": "http://www.amgen.jobs/xml/28868677/job", "country": "Netherlands", "company": "Amgen", "title": "Sr Associate QA", "reqid": "15730BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28868677}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15718BR\nJob Posting Title Clinical Operations Manager\nCareer Category Clinical\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nField Based\nAmgen Job Description Initiates and coordinates feasibility assessment, potential investigator identification\nand site selection\nStrategically plans and coordinates Amgen sponsored trials (forecasting,\nresourcing, timelines, baseline recruitment)\nAdapt ICF to local requirements\nDefines study specific processes including study communication plans\nEnsures all study staff understand study deliverables and timelines\nTracks local trial implementation, data collection and study reporting\nReviews and approves monitoring reports and Site Initiation Packages (SIPs)\nResponsible with Medical staff for vendor selection and performance evaluation for\nlocal studies, including HE studies (services other than FSP)\nProvides regular updates on study progress to DOM and study sponsors as\nrequired, identifying barriers to site activation and patient enrollment and identifying\npotential solutions\nEnsures quality of study execution\nEscalates study-related issues\nProvides Amgen presence at investigator meetings / key visits\nCoordinate & actively participate at local investigators meetings\nReview GCA Site audit reports and work in conjunction with FSP staff and Site staff\nas required to fix issues\nKey interface with Safety reporting group to oversee collection and distribution of safety reports from sites via FSP, including query follow up\nProject manages local clinical study teams\nCoordinates SACOM tasks, according to the COM-SACOM RASCI, when those are\nallocated to support COMs in the oversight of operational activities related to\nplanning, executing and reporting of phase 3 / 4 studies\nSingle point of contact at a project level for LOC staff and GSM\nPartners with Medical colleagues to exchange site relationship information and to develop Key Opinion Leaders (KOLs)\nIdentifies and highlights risk areas (concerning operational readiness,\ncommunication and management)\nEnsures CRA receives necessary TA-related and study-related training\nCoordinates local study-related administrative tasks e.g. information to finance,\nstatus update to BU, status updates in local meetings\nActively participates in the regional COM network as required\nParticipate in the hub or country level Functional Management Team (FMT Governance)\nBasic Qualifications BA/BS/BSC or qualified nurse (RN)\nwork experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained\nworking on clinical trials in a biotech, pharmaceutical or CRO company or other relevant clinical setting)\nPreferred 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\nClinical trial management experience\nOperational performance measurement experience\nInternational collaboration experience", "date_new": "2012-05-21 18:11:05", "url": "http://www.amgen.jobs/xml/28832994/job", "country": "Netherlands", "company": "Amgen", "title": "Clinical Operations Manager", "reqid": "15718BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28832994}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 15370BR\nJob Posting Title Regional Medical Liaison\nCareer Category Sales & Marketing Operations\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nField Based\nAmgen Job Description Key Activities\n\n- Supports Head Regional Medical Liason (RML)/local Therapeutic Area (TA) Leader in developing local territory R&D tactics\n- Identifies, develops and maintains collaborative relationships with current and future Key Opinion Leaders (KOLs), scientific experts, cooperative study groups and study sites\n- Develops and implements local KOL Plans, in line with local and international KOL strategy\n- Creates end execute engagement plans\n- Implements and disseminates high quality medical and scientific educational programs; gives clinical and scientific presentations at sites / hospitals\n- Identifies new research opportunities, implements and follows up on ISSs and other scientific activities, provides input to the design of local observational research\n- Works with development field operations to ensure prioritization of site selection, and support feasibility across assigned territories\n- 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\n- Represents Amgen Medical department in the territory\n- Ensures society engagement: RML support of international and regional congresses\n- Develops required qualitative and quantitative reports; collates competitor information\n- Ensures conduct of work in line with compliance regulations\n- Delivers targeted internal training for selected topics (e.g. study update, congress news, latest scientific developments)\n\nReports (at a minimum) to:\nLocal Head RML or local TA Lead\n\nResponsible for:\n- Execution of RML Plan Of Actions\n- Scientific relationships in a set territory\n- KOL profiles, plans and reports\n- Engagement plans\n- Protocol proposals and other study documents for local ISSs\n- Territory input for feasibility and site selection\n- Scientific study site support for ASTs\n- Educational programs to change medical practice\n- Scientific presentations to physicians and hospital departments\n- Field feedback: scientific trends, ongoing studies, CI\n- RML activity tracking\n\nPLEASE NOTE: An Amgen year contract is offered for this position\nBasic Qualifications - Medical or scientific education or experience from similar positions\n- Minimum 3 years of experience in industry, or a related scientific field in academia\n- Experience in sales force, affiliate Medical Department or Clinical Development\n- Willingness to travel; possesses valid driver\u2019s license\n- Experience with clinical study management and conduct\n- Scientific expertise in the therapeutic area\n- Knowledge of commercialization and business practices\n- Knowledge of regulatory affairs, drug safety, legal and compliance environment\n- Network of customer contacts\n- Medical / scientific research experience\n- Fluency in English and Dutch language is required for this role\nPreferred Qualifications - Advanced degree (e.g. PhD , MD) preferred or strong demonstration of equivalent combination of relevant educational and professional training", "date_new": "2012-04-19 20:55:12", "url": "http://www.amgen.jobs/xml/28013663/job", "country": "Netherlands", "company": "Amgen", "title": "Regional Medical Liaison", "reqid": "15370BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 28013663}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 14343BR\nJob Posting Title IS Business Analyst\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen 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.\nThe person taking this role will be responsible for International OTC processes within a global context.\nThis role will work in close coordination with other members of the Operations and SAP Center of Excellence teams in Europe and US.\nThe Business Analyst will participate in gathering requirements, design development and the review of SAP Configuration.\n\nPrimary Focus/ General Accountability:\n? 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.\n? Ongoing maintenance and configuration activities related to this space\n? Lead the development, configuration and system integration for the implementation of OTC processes in a global environment.\n? Act as in-house OTC subject matter expert and support ongoing activities.\n? Provide 3rd level support for SAP OTC/BAR users.\n? Lead / Participate in OTC change requests and projects.\n? Analyze functional requirements and drive the development of detailed functional / configuration / systems specifications and documentation.\n? Responsible for completeness and quality of functional design.\n? Provide high-level estimates for design and implementation effort.\nBasic 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).\n? Must have a strong working knowledge of SAP SD\n? Experience in global operating SAP OTC implementations.\n? Experience in Business Process Analysis & Design to make the connection between SAP and 3rd parties\u2019 distribution systems.\n? Experience in testing and production delivery.\n? Experienced in functional and technical specification development.\n? Experienced in troubleshooting and resolving SAP functional problems.\n? Understanding of complex interfaces between different SAP systems.\n? Bachelor or Master degree, preferably in Commerce/Business, Engineering or Computer Science.\n? Strong analytical skills.\n? Strong teamwork skills.\n? Strong written and oral communication skills.\n? Experience working in a regulated industry (Biotech or Pharmaceutical Industry preferred).\nPreferred Qualifications Knowledge\n- Knowledge of computer validation concepts in compliance with FDA/EMEA and other regulatory requirements.\n\nExperience\n- Systems Design Analysis\n- Network Technologies\n- Web Technologies\n- Computer Systems and Security", "date_new": "2012-03-22 18:52:24", "url": "http://www.amgen.jobs/xml/27320715/job", "country": "Netherlands", "company": "Amgen", "title": "IS Business Analyst", "reqid": "14343BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 27320715}, {"country_short": "NLD", "city": "Breda", "description": "Auto req 13960BR\nJob Posting Title Specialist QA\nCareer Category Quality\nEmployee Subgroup Salaried FT\nCountry (State/Region) The Netherlands\nLocation (City) Breda\nAmgen Job Description Objectives\nProvides the QA oversight review and approval of validation strategies and documents\nProvides QA oversight review and approval of Packaging Engineering strategies and documents\n\nPosition Specific Tasks\n\nOperational\n- Provide guidance for validation impact assessment for change control requests.\nParticipate in ABR projects and improvement efforts.\n- Ensures that Quality policies, procedures and programs are properly implemented in daily Process Development operations and remain in compliance\n- Provide coaching, guidance and compliance direction to Facilities, Engineering , Maintenance and Process Development.\n- Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications.\n- Develop solutions to complex validation problems requiring the use of ingenuity and creativity while maintaining compliant.\n- Work with project managers to complete the validation responsibilities of projects within schedule, budget and quality constraints.\n- Provide Quality oversight and approval for process development, engineering, validation projects and validation deliverables\n- Provide Quality oversight for good engineering practice documentation and system development.\n\nProcess Maintenance:\n- Ensure Validation process at the site is maintained according to Corporate and GMP requirements and procedures reflecting process are in place and effective.\n- Integrate advanced validation engineering techniques ensuring alignment with industry standards.\n- Develop and provide Validation Training\n- Act as Validation contact in corporate and regulatory inspections, as needed.\nBasic Qualifications Minimum Requirements\n- Bachelor\u2019s degree in Life Sciences or Engineering field or equivalent.\n- Typically 5+ years of related professional experience.\nOR\n- Master\u2019s degree in Life Sciences or Engineering field or equivalent.\n- Typically 3+ years of related professional experience.\nOR\n- PhD in Life Sciences or Engineering field or equivalent.\n- Typically 1+ years of related professional experience.\n\n- Fluent in English.\n- Direct experience with regulated environment required.\n- Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, CFR 11, 210 and 211.\nPreferred Qualifications Preferred Requirements\n- Typically 10+ years of related industry experience in anufacturing and/or Quality Assurance. Strong knowledge of Good Distribution Practices.", "date_new": "2012-02-16 21:59:39", "url": "http://www.amgen.jobs/xml/26576301/job", "country": "Netherlands", "company": "Amgen", "title": "Specialist QA", "reqid": "13960BR", "state": null, "state_short": null, "location": "Breda, NLD", "uid": 26576301}]