1. Job Summary   The primary purpose of this role is to work as a member of the Professional Scientific Staffing (PSS) team within the client’s laboratories to provide support within the Stability Studies function for pharmaceutical manufacture development projects.          2. Education / Experience / Skills   •         Degree in Chemistry or a related discipline is required. •         A sound, fundamental knowledge of Chemistry (Physical and Organic) is essential. •         Several years experience in a pharmaceutical analytical environment is required, with particular emphasis on stability study activity. •         Experience in authoring stability protocols to ICH guidelines. •         Experience in authoring stability sections for regulatory submissions. •         Experience in writing stability reports based on data trending, generating data tables from LIMS. •         Familiatrity in stability storage logistics, equipment and sample handling. •         Experience with traditional analytical techniques as well as modern instrumental  equipment. •         Thorough understanding of reaction mechanisms, chemical synthesis and  chromatographic techniques. •         Ability to work in and apply knowledge in a developmental and exploratory environment. •         Thorough understanding of requirements for working in a GMP environment. •         Ability to quickly learn new processes. •         Ability to work using fully electronic media, including MS Office. •         Ability to communicate clearly and to form strong working relationships with   colleagues. •         Ability to work on own initiative and be capable of developing solutions to problems as part of a team. •         Willing to operate in a flexible manner and be able to switch priorities at short notice. •         Good team player, organised, accurate, have strong documentation skills. •         Passionate about quality and customer service. •         Good communication skills both internally and externally. 3. Job Responsibilities   •         Authoring of stability protocols to ICH guidelines, for internal use and for regulatory submissions. •         Writing stability reports based on data trending, generating data from LIMS •         Working within the Stability function, and with stability storage equipment •         GMP review of the above data. •         Addressing group local audit findings. •         Participate as required in any investigations associated with their deliverables supporting this task order. •         Train existing / new analysts as necessary to ensure no disruption to the business. •         Document data as dictated by company policies and procedures. •         Attend meetings as required. •      Prepare and analyze samples as required by the appropriate technique.  Receives, prepares, labels  and stores reagents, samples and other materials as per GMPs. •         Conduct testing as per chosen technique and or applicable method. •         Identify, evaluate and report on new technological applications. •         Conduct all associated analytical instrument qualification activities •         Enter required data onto Laboratory Data Systems •         May validate data in paper or electronic notebooks and on Laboratory Data System. •         Sustain up to date knowledge on applicable department and site standard practices related to GMPs, safety and controlled substances as appropriate to work. •         Provide input, and may author procedural documents. •         Ensure that the customer gets the best possible service by continually reviewing best        practice in relation to both commercial and quality issues and ensuring 100% ethical       work standards and GMP compliance. •        Communicate regularly with the customer and when appropriate, employer to         ensure information is shared effectively and actions are taken immediately. •         Review and approve all relevant documentation in a timely manner and ensuring that it         communicated, documented, filed accurately, and compliant with the required standards. •    Review and improve commercial work practices.  Responsible for identifying areas          where efficiencies may be improved and liaising with the customer appropriately       about any proposed improvements. •     Handle any customer related queries where necessary and liaise with the team and  with personnel from other teams to problem solve these queries if needed. •     R esponsibility for the cleanliness and tidiness of the work environment, and the safety of their practices on the customer site. •         Participate as required in any investigations associated with the team deliverables. •     To be constantly aware of the customer’s requirements and strive to meet or exceed those requirements keeping in mind the customer process end points.  •     To keep up to date with any technological or method revisions in their area, ensuring their training is complete and adjusting their work as required . •     To have a clear understanding of the customer relationship and service goals . •         To ensure that all decisions are handled with customer service in mind. •     To ensure uniformity, reproducibility and reliability in all work practices.