Lead Quality Assurance Specialist

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Position: Lead Quality Assurance Specialist
Employment Type: Permanent

Department:
Quality Assurance

Work Schedule: Full Time
At Mundipharma, we are committed to enhancing the lives of patients, healthcare professionals, our partners, and our workforce.

This position is integral to the Quality Assurance team, serving as a primary resource for providing essential QA support to our manufacturing operations.

A background in Quality Assurance processes, particularly within the Pharmaceutical or Medical Device sectors, along with a solid understanding of Good Manufacturing Practices (GMP), is crucial for this role.

This position operates on a double day shift schedule, rotating weekly: Monday - Friday: 6am - 2pm / 1:30pm - 9pm.

The Lead Quality Assurance Specialist will be the initial contact for quality assurance related to manufacturing processes. Responsibilities include conducting regular inspections within operational areas to ensure ongoing compliance with GMP and organizational standards, as well as offering QA guidance as necessary.
Key responsibilities include:
  • Providing advice during deviations, including containment measures and product disposition, while overseeing and reviewing investigations and the development and execution of suitable corrective and preventive actions.
  • Leading and facilitating quality investigations to identify root causes and drive continuous improvements stemming from deviations and/or customer feedback, in collaboration with relevant departments, while communicating and tracking the implementation of corrective and preventive actions.
  • Contributing to the maintenance of compliance across all QA processes to support the company's readiness for inspections and compliance initiatives.
  • Leading or assisting in internal audits as part of the company’s self-inspection program.
  • Supporting the organization in managing quality-related risks.
  • Providing mentorship and support to junior QA team members and serving as a resource.
Qualifications:

A scientific degree in Pharmacy, Chemistry, Biology, Engineering, or a related field, or equivalent professional experience is required.

Extensive hands-on experience in QA roles within the Pharmaceutical and/or Medical Devices Industry is essential.

In-depth knowledge and application of GMP and regulatory requirements in the Pharmaceutical sector, including familiarity with Eudralex Vol. 4 Chapters and Annexes, the Orange Guide, and key EU Directives, as well as a solid understanding of the regulatory framework for pharmaceuticals.

Strong knowledge of Critical Quality Attributes of solid dosage forms and their influencing factors (e.g., friability, hardness, content uniformity, assay, dissolution profile).

Exceptional technical report writing skills and the ability to communicate effectively at all organizational levels and externally.

What We Offer:

A flexible benefits package designed to meet diverse needs.

Commitment to diversity and inclusion, fostering an environment where individuals can thrive, develop, and reach their full potential is a priority.

Join our talent community to stay informed about future opportunities at Mundipharma.

  • Lead Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Lead Quality Assurance SpecialistMarshall is seeking a Lead Quality Assurance Specialist to enhance their quality assurance team.Position Summary:Ensure adherence to quality standards and contractual obligationsIdentify potential quality challenges and develop mitigation strategiesManage the product approval processContribute quality insights throughout the...

  • Lead Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Full time

    Lead Quality Assurance SpecialistMarshall is seeking a Lead Quality Assurance Specialist to enhance their quality assurance team.Position Summary:Ensure that all quality standards are upheld according to contractual obligations.Proactively identify and address potential quality risks.Manage the product approval process effectively.Provide quality insights...

  • Quality Assurance Specialist

    4 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Quality Assurance Specialist - Cambridge A growing Medical Devices company based in Cambridge is currently looking for a new Quality Assurance Specialist to assist in the development of the QMS system for ISO 13485 standards. They are open to candidates from alternative sectors, allowing for ISO 13485 standards training. You will also be creating and...

  • Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Corriculo Recruitment Full time

    Job OverviewPosition: Quality Assurance Specialist Role SummaryWe are seeking a dedicated Quality Assurance Specialist to join our team. This position is ideal for individuals with a solid background in quality control within a manufacturing setting. The Quality Assurance Specialist will leverage their expertise in quality management and knowledge of...

  • Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Corriculo Recruitment Full time

    Job OverviewPosition: Quality Assurance Specialist Role SummaryWe are seeking a dedicated Quality Assurance Specialist to join our team at Corriculo Recruitment. This position is ideal for individuals with a solid background in quality control within a manufacturing setting. The Quality Assurance Specialist will leverage their expertise in quality management...

  • Quality Assurance Specialist

    15 hours ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key Responsibilities:Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key Responsibilities:Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Marshall Group. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesProject Quality Planning: Develop and implement project quality plans to ensure compliance with company...

  • Quality Assurance Specialist

    17 hours ago

    Cambridge, Cambridgeshire, United Kingdom Marshall Group Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Marshall Group. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesProject Quality Planning: Develop and implement project quality plans to ensure compliance with company...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom The Sterling Choice Full time £32,000 - £35,000

    About The Sterling ChoiceWe are a leading food manufacturing company dedicated to delivering high-quality products to our customers. As a key member of our team, you will play a crucial role in ensuring the quality and safety of our products.Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. The...

  • Quality Assurance Specialist

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom Evi Technologies Limited Full time

    About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team at Evi Technologies Limited. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products, particularly Ring Smart Lighting.Key Responsibilities:Collaborate with cross-functional teams to align on release...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key Responsibilities:Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Quality Assurance Specialist

    13 hours ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Engineer, you will play a critical role in ensuring the quality and safety of our Medical Devices.Key Responsibilities:Collaborate with cross-functional teams, including Mechanical Engineers, Physicists, Electronics...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom CHR Life Sciences Full time

    CHR Life Sciences is partnering with a multinational pharmaceutical company to support their clinical study lifecycle. This company connects pharmaceutical and R&D companies with patient communities worldwide, designing supply chains and delivering patient and logistics services that contribute to medical research.Purpose of the RoleThe company is seeking a...

  • Quality Assurance Specialist

    1 day ago

    Cambridge, Cambridgeshire, United Kingdom MorePeople Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at MorePeople. As a Quality Assurance Specialist, you will play a crucial role in ensuring the highest quality standards are met in our fresh produce operations.Key ResponsibilitiesQuality Assessment: Collaborate with our quality control team to evaluate the quality...

  • Senior Quality Assurance Specialist

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time

    Job DescriptionJob Title: Senior Quality Assurance SpecialistCompany: Russell TobinLocation: Cambridge (Hybrid with 2-3 days onsite per week)Job Type: Full-timeSalary: upto £21.62 PAYE and £24 per hour UmbrellaJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Russell Tobin. As a Senior Quality Assurance...

  • Senior Quality Assurance Specialist

    11 hours ago

    Cambridge, Cambridgeshire, United Kingdom Russell Tobin Full time

    Job DescriptionJob Title: Senior Quality Assurance SpecialistCompany: Russell TobinLocation: Cambridge (Hybrid with 2-3 days onsite per week)Job Type: Full-timeSalary: upto £21.62 PAYE and £24 per hour UmbrellaJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Russell Tobin. As a Senior Quality Assurance...

  • Quality Assurance Specialist

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Red Rock Partnership Full time £13

    Red Rock Partnership Limited is pleased to collaborate with a leading client in the agricultural sector who is seeking Quality Assurance Specialists to enhance their dynamic workforce.Our client stands as one of the UK's foremost producers and packers of fresh potatoes, catering to some of the nation's largest retailers and processors through multiple...

  • Quality Assurance Specialist

    15 hours ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Assurance Specialist, you will play a crucial role in the development of our Quality Management System (QMS) for ISO 13485 standards.Key ResponsibilitiesAssist in the development and implementation of our QMS systemCreate...

  • Quality Assurance Specialist

    2 days ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Newton Colmore Consulting Ltd. As a Quality Assurance Specialist, you will play a crucial role in the development of our Quality Management System (QMS) for ISO 13485 standards.Key ResponsibilitiesAssist in the development and implementation of our QMS systemCreate...