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.
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