This job is currently Archived,
Posted on : 01 May 2017
Job Summary:Under minimal supervision, responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.Contributes to team by ensuring the quality of the tasks/services provided by selfContributes to the completion of milestones associated with specific projects or activities within teamThis role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.Specific Job Duties:Support Stability Programme on site and frequent collaboration with global Stability Product Representatives (SPR) or Product Quality Leads (PQL) regarding all stability programme matters.Perform routine sample management tasks as per procedures.With a high degree of technical flexibility, work across diverse areas within QCPlan and perform routine tasks with efficiency and accuracy.Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of tasks.Report, evaluate, back-up/archive, trend and approve data.Troubleshoot, solve problems and communicate with stakeholders.Initiate and/or implement changes in controlled documents.Participate in audits, initiatives, and projects that may be departmental or organizational in scope.Write protocols and perform validation and equipment qualification/ verification. Operate and maintain specialised equipment.Introduce new techniques/ Processes to the area, where appropriate.Evaluate sample management practices for compliance and operational excellence improvement on a continuous basis.LIMS data coordination of commercial and import testing on site where applicableMay provide technical guidance.May contribute to regulatory filings.May represent the department/organization on various teams. May train others.May interact with outside resources.Perform general housekeeping in all sample management areas.Primary knowledge, skills, competencies and relevant experienceKnowledge:Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learningKnowledge of related regulatory/industry considerations, compliance issues and/or scientific discoverySkills:Take initiative to identify and drive improvementsCommunication skills (verbal and written) at all levelsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)Presentation skillsEscalate issues professionally and on a timely basisDecision Making skillsTeamwork and Coaching othersNegotiation and Influence skillsInvestigation skillsProblem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environmentDevelops solutions to technical problems of moderate complexityScreens, categorizes, evaluates, reconciles, reports, and resolves data integrity issuesInterprets generally defined practices and methodsAble to use statistical analysis tools to perform data trending and evaluationProject Management and organizational skills, including ability to follow assignments through to completionCompetencies: Demonstrated ability to work independently and deliver right first time resultsWorks under minimal direction Work is guided by objectives of the department or assignmentFollows proceduresRefers to technical standards, principles, theories and precedents as neededMay set project timeframes and priorities based on project objectives and ongoing assignmentsRecognizes and escalates problemsWorking knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleaguesAuditing documentation and operation processDemonstrated ability to interact with regulatory agenciesRelevant experience: Bachelor s degree in a Science related field is required. 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with a minimum of 2 3 years of specific sample management/ stability programme management experience. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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