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    QA Specialist I - United Kingdom - PCI TRGR Penn Pharmaceutical Services Ltd

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

    1 week ago

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    Description
    QA Specialist - Operational page is loaded QA Specialist - Operational

    Apply locations Tredegar, UK time type Full time posted on Posted Today job requisition id JR110107 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 assisting the Quality management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with current Good Manufacturing Practise standards and in accordance with company policies to meet business requirements.

    The candidate will work primarily with the manufacturing and packaging departments to provide guidance and expertise in the resolution of quality issues.

    We are expecting a pro-active candidate in influencing business unit colleagues up to director level in circumstances where conflicts arise.

    The GMP elements of Quality Assurance are essentially "on plant" activities however there may be a need to discuss issues/interface with clients.

    This is a full-time and on-site based role. There is a two s hift rotation Monday to Friday.

    Pharmaceutical products manufactured by PCI are manufactured under the most stringent regulatory and GMP requirements and must be produced to the highest ethical standards.

    Responsible for the interpretation of cGMPs for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products.

    The job holder makes a number of quality decisions which directly affect the release of materials.

    Whilst operating under such pressure to meet business deadlines, the job holder must evaluate complex data and in the absence of prescribed rules, assist in making professional judgements which could have considerable impact on the compliance and profitability of the business.

    To review non-compliance identified by audit, deviations and complaints, and use technical judgement to make the appropriate product quality decisions (in association with Quality management), and to initiate and promote quality improvements to prevent re-occurrence including attendance at daily triage meeting.

    To conduct internal performance audits and follow up actions within site business units.
    To lead and drive online triage process.
    Complete Operational GEMBA walks and drive improvements within the Quality and Operations departments.

    To play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve experimental and validation reports / protocols where appropriate.

    To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.

    To provide statistical trending reports on quality key performance indicators and to initiate corrective and preventative actions based on this data.

    To generate a monthly report on the key activities and key performance indicators for the area.
    To deputise for Quality Operations Manager where required.
    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.

    To manage and process all HR and departmental documentation for the team members including attendance, overtime, training, sickness related documents, absence requests, annual leave and staff appraisals including 1:1s, probationary reviews and PMRs.

    To supervise the work of subordinate roles in the assigned business unit or operational section. Identify self-development needs for future performance and development needs for team members/direct reports.

    Ensure compliance with company policies and procedures and internal and external Health and Safety and Environmental standards for themselves and team members.

    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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