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    QA Complaints Specialist - 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
    Life changing therapies. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

    The successful candidate will be responsible for ensuring the effective administration, monitoring and completion of quality system activities and for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.

    The nature of the role requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.

    The role demands technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.

    Responsible for the administration, monitoring and completion of Nitrosamines statements, coordinating actions between different departments.

    Daily oversight of team and QMS activities, including: adherence to, and reporting of, local and international KPIs, maintain and update the Approved Supplier List, coordinate and complete External Vendor Audits to an agreed programme, coordinate and complete annual Product Quality Reviews, conduct Internal Audits to an agreed programme, and complete assessments for of suppliers, where necessary.

    Where possible, close corrective and preventative actions or provide help.
    Use PCI software system to raise, monitor, implement and close corrective and preventative actions.
    Schedule supplier audits to comply with PCI procedures, risk assessments and in the most cost-effective way.
    Management and administration of Customer Complaints.
    Conduct GxP training to site personnel and contribute to GxP training packages where necessary.
    Ensure timely review and approval of relevant Quality documentation.
    Collation of the company Quality Management Review (QMR) information for review by Senior Management.
    Ensure appropriate investigations of deviations, errors, complaints, failures and adverse events requiring documented review and action.

    To review non-compliance identified by audit, deviations and complaints and use technical/professional judgement to make appropriate product quality decisions.

    Technical Administrator and SME for the Achiever Plus system (front end).
    Ensure that staff within area of responsibility comply with company Health and Safety Policies and Procedures.
    To manage team performance and absence standards, including coaching, counselling and disciplinary measures as required.
    To conduct performance appraisal and to set targets and objectives for individual members of the group.

    Ensure that all staff appraisals within the area of responsibility are conducted in a timely manner and in line with the approved Human Resources Policy.

    To manage the training requirements within the group to ensure regulatory compliance and business needs are met.

    Experience in a similar role in the pharmaceutical industry with up-to-date credentials relevant to both investigational and marketed products.

    Proven ability to plan work effectively, by taking a long-term view and developing structured action plans to meet business objectives.

    Must be a completion driven individual, with the attitude to drive projects to completion in considerable detail.
    Previous experience of the Achiever Plus software system would be advantageous.
    Risk Management Experience would be desirable
    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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