http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs en-GB Quanta Consultancy Services Ltd, 1993 - 2008 Fri, 23 Jul 2010 16:27:26 GMT Fri, 23 Jul 2010 16:27:26 GMT Raccoom rss generator, website http://raccoom.sytes.net, email chrisdarebell@msn.com 120 QA Specialist required supporting European new build project. Working within the Upstream Processing area of this biotech facility you will be providing in field QA Support Your role and responsibilities will be varied and will include: *Preparing documentation required for the test execution *Complete any change control documentation required (CCR's, Deviations, etc) *Review completed documentation in advance of final review by Area QA lead *Write the final OQ reports Skills/experience required: *Prior QA experience gained working within a pharmaceutical or biophrma environment *Experience with C&Q a distinct plus This contract opportunity is to start ASAP and will run until the end of the year. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/qa-field-support-engineer-geneva-switzerland-europe-j011429 Quanta Consultancy Services Ltd Fri, 23 Jul 2010 16:27:25 GMT http://quantacs.contentedmanagement.co.uk/2887 A leading European based Biotech organisation involved in an exciting expansion project has a requirement for a Configuration Manager/Database Developer for an initial 6 month contract. As the Configuration Manager working within the automation group you will be responsible for creating and documenting a well structured database for maintain PAS Configuration management information. Skills/Experience required: *Prior experience working within the pharmaceutical industry *Database development experience (MS Access & MS SQL) *Strong database manipulation skills: Able to create and run reports *Demonstrate experience of developing databases and managing conformity *MS package experience *Experience of Completing Configuration Management SOP http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/configuration-manager-geneva-switzerland-europe-j011415 Quanta Consultancy Services Ltd Mon, 19 Jul 2010 18:57:32 GMT http://quantacs.contentedmanagement.co.uk/2847 European Biotech new build project requires C&Q Technicians to support OQ activities on Automation process equipment. As part of the automation team you will be out in the field performing OQ phase testing within media prep area. Running phases (EM?s and CM?s), writing punches and being involved in deviation management. Skills/experience required: *Pharma production experience in DCS qualification (OQ *Understanding phases (EM?s, CM?s) *Experience with Yokogawa or Delta V systems http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/csv-consultant-geneva-switzerland-europe-j011426 Quanta Consultancy Services Ltd Fri, 16 Jul 2010 16:27:28 GMT http://quantacs.contentedmanagement.co.uk/2853 An experience Process Engineer is required for a position within an organisations technical operations department. The responsibilities of the position include: * Scale-up and Engineering Protocol & Report generation * Co-ordination of activities including material identification, ordering and on-site management * On the floor execution of process activities * Sample management throughout execution * Management of deviations throughout process development / Engineering activities The successful candidate's experience will include: * BSc in Science/Engineering * 2-3 Years Experience in Technology Transfer Activities including water runs, process scale-up, engineering runs and process validation This position requires an immediate start, with the potential for contract extensions. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/process-engineer--ireland-eire-europe-j011436 Quanta Consultancy Services Ltd Fri, 09 Jul 2010 08:27:31 GMT http://quantacs.contentedmanagement.co.uk/2861 Senior Associate QA required to join a biopharmaceutical company located in Holland on a permanent basis. The QA Associate will be responsible for ensuring new and revised artwork for commercial printed packaging components is compliant with approved text and GMP. They will also be required to work with RA and provide them with the appropriate samples and documents for registration purposes. Role and Responsibilities: * Check content of artwork against approved text, Change record and other references. * Review and approve new and revised artwork for commercial printed packaging components (manual and electronic proof reading). * Act as first point of contact for RA for registration requests. * Coordinate the timely supply of documents (all kinds of certificates), samples of products or printed components and reference standards for registration purposes. * Participate in internal audits as needed. * Participate in projects and improvement efforts. * Responsible for preparation of monthly metrics. * Own and maintain departmental performance board Requirements: * Good knowledge of the Dutch language * Three years experience within Quality Assurance or a Manufacturing discipline * Understanding and application of principles, concepts, theories and standards of technical/scientific field * Deepens technical knowledge through exposure and continuous learning * Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery * Applies research, information gathering, analytical and interpretation skills to problems of diverse scope * Ensures compliance within regulatory environment * Develops solutions to technical problems of moderate complexity * Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues * Interprets generally defined practices and methods * Autonomy * Works under general direction * Work is guided by objectives of the department or assignment * Refers to technical standards, principles, theories and precedents as needed * May set project timeframes and priorities based on project objectives and ongoing assignments * Recognizes and escalates problems If this is you please apply today. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/senior-associate-qa-holland-europe-j011433 Quanta Consultancy Services Ltd Wed, 07 Jul 2010 18:57:36 GMT http://quantacs.contentedmanagement.co.uk/2859 We require 4 x experienced C&Q Engineers to each complete a six month contract in Ireland. The successful consultants will have strong commissioning and validation experience and would have previous project start-up exposure. Technical experience of one of the following four areas is required: * Syringe Lines * HVAC * Component Prep - Washers and Autoclaves * Formulation - Technical Writer for test scripts These positions require an immediate start. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/cq-engineer--ireland-eire-europe-j011419 Quanta Consultancy Services Ltd Fri, 25 Jun 2010 12:27:38 GMT http://quantacs.contentedmanagement.co.uk/2849 We require an experienced validation engineer with experience of drafting and reviewing protocols. Experience of the following is desired: * Temperature controlled equipment * Water, clean steam, HVAC * SIP, autoclave sterilisation The successful consultant will become involved in execution work, once the protocols have been drafted. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/validation-engineer--ireland-eire-europe-j011391 Quanta Consultancy Services Ltd Wed, 16 Jun 2010 08:27:40 GMT http://quantacs.contentedmanagement.co.uk/2829 An excellent opportunity has become available for a Head of Process Validation for a large company to be based in either America, UK, Germany or Italy. The Head of Process Validation will be responsible for providing guidance and support for all Process Validation activities across the network. Job Description: * Participate and coordinate cross-functional teams responsible for the execution of major and minor Validation projects. * Manage and lead various best practice projects, including implementing new standards across all sites to provide consistent and improved Process Validation executions. * Develop Validation Standard Documents for both new and existing vaccine processes. * Drive and share Validation Standards associated with Process Validation across sites (champion technical training rollout). * Work with site staff to prepare budgets, schedules and business cases for Process Validation activities, and participate in presentations to both the Site and Operational Management Teams. * Evaluate current site and project Validation organizational structures and develop plans to implement high performing Process Validation departments and staff. Ensure all functional areas are covered, eliminate any gaps, and remove non-value added work. * Prepare monthly in-depth project status reports, documenting decisions, risk assessments, cost, schedule and results-oriented achievements. * Contribute to IQP (Innovation, Quality & Productivity) productivity targets at sites. * Coordinate and lead progress meetings with the site Process Validation Directors, Managers, Validation Engineers, and other associated stakeholders. * Oversee site inspection responses and ensure they are followed up on, tracked, and system improvements are delivered across the network. * Track the closure of all Process Validation gaps across each site. Minimum Requirements: * B.S., M.S., or PhD in Chemical Engineering * Expert knowledge of Process Validation with a diverse compliance background in cGMP manufacturing. * Proven track record managing Process Validation and Technical Transfer activities for new and existing processes. * Expertise in a broad range of vaccine and biotech processes. * Ability to work/live overseas - Europe, Asia, LatAm, etc. * A willingness and ability to travel, often for extended periods of time both nationally and internationally. * Preferably trained in Six Sigma / Lean Manufacturing * Project management skills, including creating / managing project budgets, resources (internal and external) and schedules. * Demonstrated organizational and leadership skills. * Demonstrated matrix management skills and clear ability to work effectively in cross functional team environments. Strong ability to lead global teams in a multicultural matrix environment. * International Experience working in cross cultural and cross functional teams is desirable. http://quantacs.contentedmanagement.co.uk/jobs/biotechnology-and-biopharma-jobs/head-of-process-validation-worldwide-j010857 Quanta Consultancy Services Ltd Fri, 19 Mar 2010 09:28:10 GMT http://quantacs.contentedmanagement.co.uk/2726