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    Data and Performance Co-ordinator - United Kingdom - PCI TRGR Penn Pharmaceutical Services Ltd

    PCI TRGR Penn Pharmaceutical Services Ltd
    PCI TRGR Penn Pharmaceutical Services Ltd United Kingdom

    2 weeks ago

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    Description
    Stability Coordinator - Level 1 page is loaded Stability Coordinator - Level 1

    Apply locations Tredegar, UK time type Full time posted on Posted Yesterday job requisition id JR109932 Life changing therapies.

    Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

    The purpose of the role is to organise and manage all stability studies within the Analytical Services department and to ensure that stability time points and sample pulls comply with relevant procedures and Client expectations and data is reported in line with Technical Agreements, Internal procedures, and client expectation.

    This role is also responsible for leadership of the stability study management within Analytical Services Group ensuring timely co-ordination of routine stability analysis, with respect to set down and pull dates in line with business needs.

    To lead and drive the management of stability studies within Analytical Services to achieve the required business standards in terms of quality, safety, KPI's, etc.

    To maintain stability inventory and facilities.

    To generate and authorise technical documentation (including stability protocols and stability reports) and to routinely participate in review procedures in relation to stability testing activities.

    To maintain a thorough understanding of international regulatory and ISO requirements pertinent to the role and to ensure that this information is made available to the team, with departmental procedures and the principles of GMP.

    To ensure that all stability study co-ordination activities including those of sub-contract facilities providing a service to the team and co-ordination team investigations, deviations and change controls are complied with, subject to there being no attenuating circumstances.

    To carry out and manage projects within the department and at international level, as required.
    Review and improve departmental processes and eliminate waste.
    To identify self-development needs for future performance.

    To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities and responsibilities.

    Minimum Degree in a Scientific Subject (preferably Chemistry or Microbiology).
    The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
    GMP Requirements Hierarchy and GMP Skill Level 1 is essential for this role.
    Significant experience within the pharmaceutical industry.
    Join us and be part of building the bridge between life changing therapies and patients.

    We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

    Why work for PCI Pharma Services?

    At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.

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