Jobs
>
Southampton

    Head of Quality Assurance - Southampton, United Kingdom - TLA Group

    TLA Group
    TLA Group Southampton, United Kingdom

    5 days ago

    Default job background
    Description
    We currently have this exciting role within the Pharmacy department for a Head of Pharmacy QA
    This post will be Monday - Friday and ongoing

    Postholder will provide senior strategic leadership on all aspects of quality assurance in relation to pharmaceutical manufacturing and preparation in UHS aseptic and radiopharmaceutical services.

    # To lead with respect to all quality and regulatory aspects of design, commissioning and maintenance of the Adanac Aseptic Hub facility.
    # To act as a Qualified Person (QP), responsible for assuring the quality of medicines as defined in the Human Medicines Regulation 2012/1916, on the Manufacturing Authorisation as required.
    To manage MHRA licence applications, MHRA Licence(s), liaising with MHRA and supporting regulatory inspections.


    Provides technical QA resource, advice and support to ensure GMP compliance at the manufacturing sites (Radiopharmacy & Adanac Aseptic Hub).

    This includes attendance at MHRA inspections which are essential for continuity of the Hubs manufacturing licence.
    # Undertake an extensive programme of regular quality audit across pharmacy services in line with standards, reporting deficiencies to service managers. Ensure the pharmacy quality control laboratory service proactively identifies, and assesses the significance of, potential QA system failures, through daily and weekly monitoring. 40%) of their working week reviewing, developing and responding to quality audit.
    # In conjunction with pharmacy and radiopharmacy technical services leads, advise senior pharmacy and Trust managers on matters relating to pharmaceutical aseptic preparation and manufacturing services, with regard to the Medicines Act 1968, and related standards. Initiate testing, monitoring and technical audits of radiopharmaceutical products and manufactured and prepared medicines.
    # To act as a Responsible Person Import (RPi) on the Hub WDA(H).
    # To ensure the delivery and maintenance of a GMP compliant aseptic manufacturing unit.
    # Review, organise, update, manage and maintain the quality control laboratory facilities to meet service requirements and Good Laboratory Practice (GLP) ensuring all testing is performed by trained analysts on suitably qualified equipment using validated methods. To ensure a GMP (annex 15) compliant validation master plan is created to define the risk-based approach to the validation of facilities and equipment including the definition of ongoing maintenance and monitoring schedules.
    # Be responsible for the management and strategic development of the QA service and team, including responsibility for recruitment, appraisal, performance and absence management of staff.
    # Responsible for Quality Assurance department's budget including all necessary equipment purchases. High level Signatory for QA/QC budget involving selection of suppliers.
    # Manage the specialist provision of the medical gas testing service according to UK / European standards.
    Ensure staff and contractors providing these services are appropriately competent and approved to undertake this work.
    Authorise 'Permit to Use' certification for medical gases in conjunction with the Authorised Engineer.
    # Act as system administrator for remote temperature monitoring relating to the Wellcome Trust Clinical Research Facility, catering, pharmacy and Radiopharmacy.
    # Manage the specialist provision, on contract, of quality assurance services and advice to other NHS and private pharmacy technical services units and sterile services units, including the preparation of formal audit reports.
    # To be responsible for the QA systems in relation to Good Manufacturing Practice (GMP) including the design, build and maintenance of a pharmaceutical quality system.
    # Assess and evaluate new equipment before purchase and before use in collaboration with pharmacy technical services managers and the Radiopharmacy Manager.
    # Ensure the requirements of the Control of Substances Hazardous to Health (CoSHH) regulations are met for all aspects of pharmacy work and in relation to any use of medicines across the Trust.
    # Design, implement and assess competence in training programs for QA staff and other pharmacy staff rotating through QA services. In addition, provide training to other pharmacy and Trust staff and university undergraduates in the principles of quality assurance, quality control and pharmaceutics. Act as a tutor or mentor for senior pharmacy or Trust staff.
    # Manage the systems for all external drug and related medical device defects and recalls.
    # Lead the preparation of tender documents and evaluation of tender submissions relating to the aseptic services and wider pharmacy.
    # Leading and developing a highly skilled and expert team to oversee audit and assurance to ensure robust conformity to national regulatory and good practice standards.
    # Communicates in complex technical areas with a wide range of people, including Senior Trust Managers, Contractors and Regulators.
    # Needs to authoritatively interpret and explain Good Manufacturing Practice in order to influence practices in all pharmaceutical manufacturing and preparation sites. In addition, the post holder is required to communicate highly complex, technically demanding information to influence MHRA Regulatory Authority inspectors at inspections and accreditations.
    # Communicates with Senior Clinicians, Trust Managers, Aseptic Network staff, Chief Pharmacists regarding highly complex technicalities of legislation and other QA related issues, whilst being mindful that there may be barriers to understanding. Attends National and Regional Quality Assurance Meetings as required by NHSE, ICS and associated National Working Groups and Regional meetings as required.
    # Confidentiality of data must be respected.
    # Liaises with suppliers and manufacturers, to obtain scientific data relating to individual medicines with regard to their quality.

    #
  • Novacyt Group

    Quality Assurance

    20 hours ago

    Novacyt Group Eastleigh, United Kingdom

    Supporting the Primer Design Ltd Quality team responsible for the continuing improvement and maintenance of the Quality Management System (QMS) in compliance with all relevant standards identified by the company. The QA Specialist will report directly to the Quality Manager and w ...

  • Redlinegroup

    Quality Assurance Administrator

    1 day ago

    Redlinegroup Hampshire, United Kingdom

    Location: · - Hampshire- Sector: · - Quality- Job type: · - Permanent- Job reference: · - LAP1281- Salary: · - Up to £26,000 plus benefits- Are you looking to work for a global leading engineering business? Are you looking to develop and progress your career within a Quality Assu ...

  • Kier Group

    Quality Assured Advisor

    1 day ago

    Kier Group Basingstoke, United Kingdom

    We're looking for a Quality Assured Advisor to work within our Ministry of Justice and Home Office Contract Administration team. Within this role, you can enjoy exposure to exciting projects, a Rewards and Benefits package, progressions opportunities and even more. · **Location** ...

  • Simplyhealth

    Quality Assurance Team Leader

    1 day ago

    Simplyhealth Andover, United Kingdom

    **About The Role**: · *** · - We're looking for an experienced Team Leader to join and head up our · - **Quality Assurance Team** for the next · - **12** · **months**. This exciting opportunity will develop your leadership, change management and QA skills Customers are at heart o ...

  • Pioneer Selection Ltd

    Quality Assurance

    2 days ago

    Pioneer Selection Ltd Dorset, United Kingdom Full time

    JOB TITLE: Quality Assurance - FMCG Manufacturing Company Salary: £27,000Location: DorsetShift: Perm EarlyWe are looking to recruit a Quality Assurance professional where you'll play a pivotal role in ensuring the highest standards of quality and compliance in the FMCG industry. ...

  • Safran Helicopter Engines

    Quality Assurance Leader

    18 hours ago

    Safran Helicopter Engines Whiteley, United Kingdom Permanent - Full time

    Job Description · What's special about us? · Safran Helicopter Engines are the world's leading manufacturer of rotorcraft turbines and the only one dedicated exclusively to this market. · Our UK facility is the European Maintenance Centre Hub for the SHE Group, performing level ...

  • Copello Global

    Quality Assurance Engineer

    3 days ago

    Copello Global Fareham, Hampshire, United Kingdom

    Copello are recruiting for a Quality Assurance Engineer to join a Defence services business based in Fareham. The role is in place to provide vital support in assuring the delivery of products, programmes and service. · Duties will include: · Providing quality assurance through ...

  • Copello Global

    Quality Assurance Engineer

    5 days ago

    Copello Global Fareham, United Kingdom

    Job Description · Copello are recruiting for a Quality Assurance Engineer to join a Defence services business based in Fareham. The role is in place to provide vital support in assuring the delivery of products, programmes and service. · Duties will include: · Providing quality a ...

  • Copello Global

    Quality and Assurance Engineer

    3 days ago

    Copello Global Fareham, Hampshire, United Kingdom

    Copello are recruiting for a Quality Assurance Engineer to join a Defence services business based in Fareham. Providing quality assurance throughout programme and product lifecycle and acceptance events, assuring effective governance. · Focusing on the quality of suppliers' deli ...

  • SAAB Seaeye

    Quality Assurance Auditor

    5 days ago

    SAAB Seaeye Fareham, United Kingdom

    Introduction · Saab UK is a British company that is part of Saab Group's global high-technology operations. Saab offers world-leading solutions and services in defence, aviation, space and civil security. In the UK we bring together the best of Swedish and British innovation an ...

  • Safran

    Quality Assurance Leader

    19 hours ago

    Safran Fareham, United Kingdom

    What's special about us? · Safran Helicopter Engines are the world's leading manufacturer of rotorcraft turbines and the only one dedicated exclusively to this market. · Our UK facility is the European Maintenance Centre Hub for the SHE Group, performing level 1 to level 3 maint ...

  • Purosearch

    Quality Assurance Manager

    1 week ago

    Purosearch Bournemouth, Dorset, United Kingdom

    Quality Assurance Manager / Clinical Area Manager / Regional Clinical Manager. · £68k + car + Bonus · Dorset · Quality Assurance Manager / Clinical Area Manager / Regional Clinical Manager required to join major care provider. You will join a truly market leading care provider wi ...

  • Energy Jobline CVL

    Quality and Assurance Engineer

    6 days ago

    Energy Jobline CVL Portsmouth, Hampshire, United Kingdom

    Source Solutions are proud to be recruiting a Quality Assurance Engineer on behalf of a highly successful but continually and rapidly growing global manufacturer within the electronics space, who operate cutting edge technology within a fascinating environment and a culture of co ...

  • Holt Engineering Recruitment Limited

    Quality and Assurance Engineer

    1 day ago

    Holt Engineering Recruitment Limited Poole, Dorset, United Kingdom

    Quality Assurance Engineer · We are currently partnering with a globally renowned manufacturing business on their business growth, and part of that is the requirement for more skilled staff including this vacancy for a Quality Assurance Engineer. · TheQuality AssuranceEngineer ...

  • Bennett And Game Recruitment

    Quality and Assurance Engineer

    4 days ago

    Bennett And Game Recruitment Poole, Dorset, United Kingdom

    Quality Assurance Engineer required. Our client is a well-established and growing procurement specialist in the engineering sector, based in the Poole area. · Due to continued success, they are seeking a Quality Assurance Engineer to join the team to take responsibility for veri ...

  • Southern Health NHS Foundation Trust

    Post Graduate Medical Education Senior Administrator

    1 day ago

    Southern Health NHS Foundation Trust Southampton, United Kingdom

    To work with the Director of Medical Education, the Postgraduate Medical Education Team Lead, locality Tutors and the Wessex School of Psychiatry to schedule and organise face-to-face and online meetings, training and education events to support the education programme for traine ...

  • Bond Williams Limited

    ACA/ACCA - Financial Reporting Mgr - Southampton -

    1 day ago

    Bond Williams Limited Southampton, United Kingdom Full time

    A Financial Reporting Manager/Senior Manager is being recruited for one of the UK's leading professional services group to be based in their Southampton office. They offer a range of financial and professional services to individuals, trusts, professional intermediaries, charitie ...

  • Ordnance Survey

    Senior Internal Auditor

    20 hours ago

    Ordnance Survey Southampton, United Kingdom

    At OS, our vision is to be recognised as world-leaders in geospatial services, creating location insight for positive impact. We use our valuable data and know-how to help drive the future success of Britain and other nations. We facilitate important decisions that enhance the qu ...

  • TFP Fertility

    Embryologist

    1 day ago

    TFP Fertility Southampton, United Kingdom

    **Purpose statement**: · At TFP, we make families. We shape fertility journeys around people's lives. We provide an outstanding patient experience by showing that we care, build trust, deliver our expertise, drive innovation, and demonstrate our patients our passion on a day-by-d ...

  • Lester Aldridge

    Senior Associate 4-8 Yrs Pqe

    20 hours ago

    Lester Aldridge Southampton, United Kingdom

    **Job type: Permanent, full-time** · Lester Aldridge have an exciting opportunity for an experienced planning lawyer to join our busy Chambers ranked Planning and Infrastructure team, primarily based in our Southampton office. · You will have gained extensive experience within th ...