Quality Assurance Specialist

4 weeks ago

Moreton Merseyside, United Kingdom Gibbs Hybrid Programme Solutions & Consultancy Full time

QA Specialist

Moreton, GB (Hybrid)

12 Month Contract – Likely Extensions/ permanency

£20 per hour

Function

PDQ Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures.

Key responsibilities include drug substance and drug product batch disposition (release/reject decision), product certification and release by the UK/EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.

Primary Responsibility:

  • Review and label vendor specifications in accordance with relevant regulatory requirements for assigned projects.
  • Review and approve vendor generated label proofs/specifications and other related documents.
  • Utilizes electronic verification software to perform check on label proof. Routes final label for review and approval accordingly.
  • Work cross-functionally with individuals and project teams.

Other Responsibilities

  • Performs specific quality related functions such as Quality/GMP training, materials/products releasing, validation, quality incident investigations to ensure compliance with GMP regulations and standards.
  • Supports in the investigation of non-conformances and quality incidents. Resolves and documents any deviation or problem pertaining to the audit of documents.
  • Reviews and approves documents related to Quality Systems such as validation protocols/reports, change control, or Procedural Documents to support the release function.
  • Support internal and/or external audits as required.
  • Participates in assigned training including GMP and safety training.
  • Ensures regulatory, GMP, GDP compliance of activities in assigned areas of responsibility. Reports any deviations to the appropriate management.
  • Liaises with responsible Trial Supplies Manager on aspects of clinical supplies packaging and labelling design and study requirements and resolves issues.

Competencies Required:

  • Ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
  • Attention to detail and a strong ability to concentrate
  • Exceptional project management skills and detail oriented.
  • Possesses solid oral and written communication skills.
  • Good decision making and organizational skills.
  • Ability to effectively communicate ideas and to influence others to achieve results.
  • Ability to understand and apply regulatory and CGMP principles.
  • Good understanding of pharmaceutical or medical terminology
  • Proficiency in standard office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) Additional applications such as Adobe. Willing to learn additional applications as needed.
  • Experience working on multi-disciplinary teams and projects.
  • Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g., revision control) is preferred.

Experience:

  • Bachelor's degree or equivalent in pharmacy, engineering, or life sciences.
  • Relevant experience in the pharmaceutical industry or related healthcare environment.
  • Labelling experience in the pharmaceutical industry is highly desired.

If you are interested, please do not hesitate to apply Either apply direct or reach out Curtis.Sharpe@GibbsHybrid.com

  • Quality Assurance Controls Manager

    3 weeks ago

    Merseyside, United Kingdom Careers In Group Full time

    Our client, one of Merseyside's most prestigious and well established financial services organisations is looking for a Quality Assurance Controls Manager for a 12 month Fixed Term Contract. This role exists to support a high-profile, organisation-wide project, and will support both the project team and the risk team. Responsibilities in this role will...

  • Quality Assurance Associate

    6 days ago

    Merseyside, United Kingdom Regulatory Professionals Full time

    **Reference Number: JO-2302-510797** Quality Assurance Associate Rate: Negotiable **Job Type**: Contract Location: Moreton, Merseyside Quality Assurance Associate l 12 Month Contract £19.23 per hour PAYE, 35 hours per week Merseyside - 50/50 Hybrid working Key Responsibilities - Project Manage/support the External QP release process. -...

  • Quality Assurance Associate

    6 days ago

    Merseyside, United Kingdom Thornshaw Scientific Recruitment Full time

    Posted date 17 February 2023 - LocationMerseyside - Job type Contract - SalaryNegotiable - Discipline Life Sciences - ReferenceJO-2302-510797 - Work Location Hybrid Quality Assurance Associate l 12 Month Contract £19.23 per hour PAYE, 35 hours per week Merseyside - 50/50 Hybrid working Key Responsibilities - Project Manage/support the External QP...

  • Quality Assurance Officer

    4 weeks ago

    Sefton, Merseyside, United Kingdom Sefton Full time

    Supported by Youth Employment Initiative & European Social Fund Our ' Ways to Work ' Programme can help you to find work! Our client is recruiting for a part time Quality Assurance Officer, based at our offices in Knowsley Road, Bootle. Job Title: Quality Assurance Officer Hours of Work: 21 hours per week (part time) To provide high quality...

  • Sterility Assurance

    4 weeks ago

    Merseyside, United Kingdom Thornshaw Scientific Recruitment Full time

    Posted date 17 April 2023 - LocationMerseyside - Job type Temp - SalaryNegotiable - Discipline Life Sciences - ReferenceJO-2304-514296 Sterility Assurance 12 month contract £20-£25 per hour Liverpool Cpl Life Sciences are partnering with a global pharmaceutical company that focusses on developing life changing vaccines recruiting for a Sterility...

  • Quality Engineer Engineering

    2 days ago

    Eccleston, Merseyside, United Kingdom Guidant Global Full time

    A great opportunity has arisen in Airbus UK Broughton for someone to join the Quality Team as a Quality Lineside Engineer. The successful candidate will be supporting the evaluation, coordination and monitoring of achieved levels of conformity in the product, process and services provided by the Business. Key Responsibilities To provide specialist Quality...

  • Quality Lineside Engineer

    2 days ago

    Eccleston, Merseyside, United Kingdom Guidant Global Full time

    A great opportunity has arisen in Airbus UK Broughton for someone to join the Quality Team as a Quality Lineside Engineer. The successful candidate will be supporting the evaluation, coordination and monitoring of achieved levels of conformity in the product, process and services provided by the Business. Key Responsibilities To provide specialist Quality...

  • Quality Lineside Engineer

    4 weeks ago

    Eccleston, Merseyside, United Kingdom Morson Talent Full time

    Morson are teaming up with a leading Aerospace and Defence client in the Broughton area looking for their next Quality Lineside Engineer. Job title: Quality Lineside Engineer Location: Chester/Broughton Rates £30.10 per hour Umbrella £22.75 per hour PAYE Double day shift pattern (alternating weeks) Week of mornings – 6:00am – 1:10pm Week of...

  • Quality Engineer Engineering

    4 weeks ago

    Eccleston, Merseyside, United Kingdom Morson Talent Full time

    Morson are teaming up with a leading Aerospace and Defence client in the Broughton area looking for their next Quality Lineside Engineer. Job title: Quality Lineside Engineer Location: Chester/Broughton Rates £30.10 per hour Umbrella £22.75 per hour PAYE Double day shift pattern (alternating weeks) Week of mornings – 6:00am – 1:10pm Week of...

  • Quality Lineside Engineer

    4 weeks ago

    Eccleston, Merseyside, United Kingdom Morson Talent Full time

    Morson are teaming up with a leading Aerospace and Defence client in the Broughton area looking for their next Quality Lineside Engineer. Job title: Quality Lineside Engineer Location: Chester/Broughton Rates £30.10 per hour Umbrella £22.75 per hour PAYE Double day shift pattern (alternating weeks) Week of mornings – 6:00am – 1:10pm Week of...

  • Quality Engineer Engineering

    4 weeks ago

    Eccleston, Merseyside, United Kingdom Morson Talent Full time

    Morson are teaming up with a leading Aerospace and Defence client in the Broughton area looking for their next Quality Lineside Engineer. Job title: Quality Lineside Engineer Location: Chester/Broughton Rates £30.10 per hour Umbrella £22.75 per hour PAYE Double day shift pattern (alternating weeks) Week of mornings – 6:00am – 1:10pm Week of...

  • Registered Manager

    3 days ago

    Gateacre, Merseyside, United Kingdom Quality Care Group Full time

    Job Title: Care Home Manager - Learning Disabilities Employment Type: Permanent, Full-time 35 hrs a week Quality Care Recruit is recruiting for Learning Disabilities Home Manager in Liverpool: Our client is an established not for profit organisation with a history spanning 3 decades, dedicated to providing innovative and person-centered care services...

  • Director of Care, Quality

    4 weeks ago

    Kensington, Merseyside, United Kingdom Gilbert Meher Ltd Full time

    Job Title: Director of Quality & Governance Join the most prestigious and luxurious care provider in the UK, where exceptional care meets opulence. Our exclusive homes are nestled in prime locations, including Notting Hill and Chelsea, with exciting new builds in the pipeline for 2024. We redefine the standards of care, combining the highest level of service...

  • Director of Quality

    4 weeks ago

    Kensington, Merseyside, United Kingdom Gilbert Meher Ltd Full time

    Job Title: Director of Quality & Governance Location: London, UK Salary: Negotiable Company: Join the most prestigious and luxurious care provider in the UK, where exceptional care meets opulence. Our exclusive homes are nestled in prime locations, including Notting Hill and Chelsea, with exciting new builds in the pipeline for 2024. We redefine the...

  • Graduate Engineer

    4 weeks ago

    Bromborough, Merseyside, United Kingdom Nicholas Associates Full time

    As a Quality Engineer, you will be working as part of the growing Quality department team, providing product and process quality assurance across the production environment. Providing inputs to the Quality and Compliance managers to aid continuous development of quality processes, training and CI projects. To support the Quality and Compliance Managers in...

  • Uk Product Specialist

    7 days ago

    Merseyside, United Kingdom Mast Group Limited Full time

    **Applicant requirements include** Formal qualification/BSc in Molecular Biology or BMS and expeirence in sales within the UK IVD market. **The Role** - To lead customer facing sales promotions - Propose and develop the strategy, tactics and products required in support of PoC clinical markets. - Ensure growth in total revenue and margins ahead of...

  • Locum Specialist Registrars in Obs

    6 days ago

    Merseyside, United Kingdom Skilled Medical Full time

    Merseyside 13 Mar 2023 - 19 Mar 2023 TBA Specialty Registrar - Yrs 3-7 Obstetrics and Gynaecology - Ongoing locum work available with this client - Various shift times to choose from **Details**: Locum Specialist Registrars in Obstetrics & Gynaecology required for a Liverpool hospital.- full GMC registration with a licence to practice - have the Right to...

  • Nursery Room Leader

    1 week ago

    Wirral, Merseyside, United Kingdom Hays Specialist Recruitment - Education Full time

    We are currently working with a nursery on the Wirral that is actively recruiting a baby room leader to work in their busy day nursery on a 38 hour-week basis over a 4-day period. Hours: 8am - 6pm with one day off during the week. About the nursery: A Wirral nursery is a much-loved, family-run childcare centre and pre-school located in Meols, Wirral....

  • Nursery Room Leader

    7 days ago

    Wirral, Merseyside, United Kingdom Hays Specialist Recruitment - Education Full time

    We are currently working with a nursery on the Wirral that is actively recruiting a baby room leader to work in their busy day nursery on a 38 hour-week basis over a 4-day period. Hours: 8am - 6pm with one day off during the week. About the nursery: A Wirral nursery is a much-loved, family-run childcare centre and pre-school located in Meols, Wirral....

  • Maths Teacher

    3 weeks ago

    Sefton, Merseyside, United Kingdom Hays Specialist Recruitment - Education Full time

    Your new school Teacher of Mathematics- Sefton Secondary School Job Type: permanent Start Date: September 2024 MPS/ UPSJob DescriptionWe are seeking an enthusiastic and committed Teacher of Mathematics for a secondary school in Sefton. The successful applicant will be expected to deliver engaging and innovative lessons, inspire students, and play a key role...