Quality Assurance Compliance Software Specialist

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Job description

Job SpecificationWe offer:Vibrant and dynamic employment - we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and excitingOpportunities to develop your skills and yourself - our rapid growth brings greater opportunities for you to learn and grow faster!A great team where we all support each other - enjoy your work - after all you spend about a third of your time here!Our Company:"We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world's leading pharmaceutical companies, solving some of the most difficult scientific challenges".We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.We are based in the vibrant city of Liverpool with world class R&D and manufacturing facilities that offer a complete end to end biopharmaceutical development service.Our Liverpool team has a remarkable 20 year track record in biologics development over which time we have acquired a great deal of collective experience and technical know-how in successful drug development - from very early pre-clinical studies through to supporting phase 3 trials, process characterisation, process validation, pre-approval inspection and market authorisations in North America, Europe, Japan, China and elsewhere.Pharmaron's 80,000 sq. ft Liverpool facility comprises state of the art laboratories for process development, analytical development, product characterisation and QC. Our licenced drug substance GMP facility has two independent viral vector GMP suites and a 3rd suite dedicated to microbial plasmid. Pharmaron has an ambitious growth strategy and there are plans for significant expansion on our 7 acres plot.The Liverpool team are highly collaborative and are used to working as part of customers integrated drug development teams within a fast-paced but supportive pharma environment. Due to our exciting portfolio we are now recruiting for a Quality Assurance Compliance Software Specialist.We offer a competitive salary and a progressive and comprehensive suite of employee benefitsWe offer state of the art working environment in our modern Liverpool siteWe offer the opportunity for growth and development and will support funding for relevant training and development programmesWe do more than manufacture batches, we develop medicines!The QA Compliance Software Specialist will be a valued member of the Quality Assurance team who support the Liverpool procurement function and Liverpool site. The role will be the compliance software administrator and super user for QA Compliance Software applications. The role will also support the installation and validation of software applications in line with data integrity requirements.Responsibilities:Lead the administration of Compliance software applications such as TrackWise, eLMS and One Vault (EDMS)Support configuration of user groups and access levels.Create and manage application workflows as required ensuring highest standards of data integrity and robust audit trails.Perform validation of application templates and reports.Lead the installation, configuration and qualification of new systems/software into the Liverpool network.Works closely with IT Services groups and the third-party vendors to ensure that technology platforms are adequately supported and monitor compliant system use.Ensure appropriate data back up plans are implemented for all Compliance Applications and manage data retention according to approved policies and procedures.Implement Business Continuity and Disaster Recovery Procedures for Compliance software applications.Monitor and Re-Route Incomplete Workflows / Records as requiredResponsible for change management processes and re-validation activitiesInitiate and facilitate discussions for business process design/redesign and input into the evolution of the technology landscape for laboratory information management.QualificationBachelor's Degree in Science or related field, plus significant practical experience in an industrial setting; or an equivalent combination of education and experience.Quality Assurance experience within a Pharmaceutical, CRO or Biotech company.Strong experience and expertise in the maintenance and administration of Compliance applications used in the pharmaceutical industry; including regulatory/audit requirements.Good understanding of information management plus Compliance systems and business processes and how they fit into the overall drug development/manufacturing process would be an advantage.Familiarity with change management including business process design/redesign, solution design, development, implementation and data integration of Compliance systems.Understanding of compliance and regulatory standards e.g. GMP preferred.Proficient in analysing and troubleshooting problems; identifying solutions; and recommending and implementing methods, procedures and techniques for resolution and elimination of root cause.Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 12,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.