![Clevry UK Ltd.](https://media.trabajo.org/img/noimg.jpg)
GxP Quality Assurance Expert
3 days ago
Job Description:
Clevry UK Ltd. seeks a seasoned Senior GxP Auditor to oversee the development and execution of a global risk-based audit strategy, driving compliance with GMP/GDP regulations.
Key Responsibilities:
- Strategy Development: Create and implement a comprehensive global audit strategy, emphasizing quality and regulatory excellence.
- Audit Leadership: Guide external GxP audits of CMOs, suppliers, and service providers, promoting timely completion and effective follow-up.
- Internal Audit: Conduct internal audits and self-inspections, fostering an environment of continuous improvement.
- Regulatory Guidance: Offer authoritative advice on regulatory compliance, empowering business growth through best practices.
- Critical Issue Resolution: Swiftly escalate and resolve critical findings, ensuring seamless implementation of CAPAs.
- Performance Analysis: Compile audit status reports, highlighting trends and performance metrics that inform strategic decision-making.
- Collaboration: Support authority inspections and partner audits, demonstrating seamless integration with global partners.
- Knowledge Management: Maintain expert-level proficiency in FDA, EU, and ICH regulations, staying abreast of evolving regulatory requirements.
- Process Optimization: Author SOPs that streamline GxP audit processes, minimizing operational hurdles.
- Business Expansion: Leverage GxP compliance consulting to drive business growth through strategic initiatives and process improvements.
Eligibility Requirements:
- Life Sciences University Degree.
- At least 10 years of experience in the pharmaceutical industry with GMP/GDP responsibilities.
- Strong background in GMP/GDP audits and inspections.
- Desirable: Experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing.
-
Quality Assurance Manager
5 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeRole DescriptionThe Sobi Group is looking for a talented and dedicated Regulatory Affairs Professional to support our team in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.Key ResponsibilitiesAct as a liaison between the business and regulatory bodies, ensuring...
-
Quality Assurance Manager
6 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeWe are looking for a Quality Assurance Manager who can lead our efforts in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.This role will support the company's vision of 'Ensure eCompliance and Goes digital to enable Quality decisions driven by data' by overseeing GxP...
-
Quality Assurance Manager
4 days ago
Stockholm, Stockholm, Sweden Clevry Sweden AB Full timeClevry Sweden AB is a dynamic company that values expertise and innovation. We are seeking a Senior GxP Auditor to join our team and support the development of our global risk-based audit strategy. As a member of our Quality Assurance team, you will play a vital role in ensuring compliance with GMP/GDP regulations.Job SummaryThe Senior GxP Auditor will be...
-
GxP Compliance Specialist
13 hours ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeWe are looking for a skilled Quality Assurance Manager to join our team at Sobi, a specialized biopharmaceutical company dedicated to rare diseases. In this role, you will be responsible for leading and managing Computer System Validation (CSV) to ensure e-compliance of GxP systems. This involves overseeing Quality Data Stewards, evaluating and approving...
-
Quality Assurance Strategist
5 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeAbout the CompanySobi is a specialized biopharmaceutical company that has made significant contributions to the field of rare diseases. With a strong focus on quality and compliance, we are seeking a skilled professional to join our team as a GxP e-Compliance Manager.As a member of our team, you will be responsible for leading and managing CSV initiatives,...
-
Quality Assurance Manager
14 hours ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeAbout Sobi">Sobi is a specialized biopharmaceutical company dedicated to rare diseases. We turn our research into ground-breaking treatments, making medicine more accessible and opening up possibilities for patients and those caring for them.">Job Description">">Lead and manage Computer System Validation (CSV) to ensure e-compliance of GxP systems.">Oversee...
-
Quality Assurance Expert
1 hour ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAbout the RoleAt Digital Realty, we are seeking a Quality Assurance Expert to join our team in Stockholm. As a key member of our Nordic Quality team, you will play a crucial role in ensuring compliance with internal and external quality and information security requirements.The ideal candidate will have a proven track record of maintaining and upholding...
-
Quality Assurance Expert
23 hours ago
Stockholm, Stockholm, Sweden Alfa Laval Mid Europe GmbH Full timeJob Description:We are currently seeking a Quality Assurance Expert to oversee the quality of our products and ensure customer satisfaction.The successful candidate will have a technical background, knowledge of ISO standards, and experience in systematic quality work. They will be responsible for managing medium to large projects, coordinating key...
-
Software Quality Assurance Expert
3 days ago
Stockholm, Stockholm, Sweden GeekSoft Consulting Full timeAbout the Role:We are looking for a Software Quality Assurance Expert to join our team at GeekSoft Consulting.This role involves helping to design, build, and continuously improve our clients online platform.The successful candidate will have a strong understanding of software quality assurance principles and be able to define test scenarios and expected...
-
Test Analyst and Quality Assurance Expert
4 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeTN Sweden's Commitment to QualityAt TN Sweden, we are dedicated to delivering high-quality products and services. As a Test Analyst and Quality Assurance Expert, you will play a key role in ensuring that our software meets the highest standards of quality.Key Responsibilities:Analyzing user stories to identify testing requirements.Designing and executing...
-
Quality Assurance Director
2 days ago
Stockholm, Stockholm, Sweden Brite AB Full timeAbout the PositionThis technical QA manager role involves leading our skilled QA team in developing and implementing effective QA strategies, toolsets, and processes. Key responsibilities include:Guiding the QA and Test domains in developing and implementing QA strategies.Providing expert advice and support to Engineering teams to enhance their quality...
-
Senior GxP Compliance Specialist
5 days ago
Stockholm, Stockholm, Sweden Clevry Sweden AB Full timeAt Clevry Sweden AB, we are seeking a highly skilled Senior GxP Auditor to support the development of our global risk-based audit strategy. This key role is responsible for ensuring compliance with GMP/GDP regulations while collaborating with cross-functional teams to maintain the highest standards in quality and regulatory compliance.Job DescriptionWe are...
-
Digital Quality Specialist
6 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeAt Sobi, we are seeking a detail-oriented Digital Quality Specialist to ensure eCompliance through robust GxP system management and data stewardship. The ideal candidate will have strong analytical skills to drive digital quality initiatives and identify process improvements.This role plays a pivotal part in overseeing GxP systems and its data processed in...
-
Senior Quality Assurance Manager
2 hours ago
Stockholm, Stockholm, Sweden VIPAS AB Full timeVIPAS AB, a pioneering IT consulting company, invites you to join its vibrant team as a Senior Quality Assurance Manager.As an expert in software validation, you will play a pivotal role in driving the development and improvement of test processes. Your responsibilities will include planning, evaluating test results, and providing recommendations on approval...
-
Quality Assurance Professional
3 days ago
Stockholm, Stockholm, Sweden Tbwa ChiatDay Inc Full timeQuality Assurance Professional:We are seeking an experienced Quality Assurance Professional to join our team in the exciting field of iGaming. As a key member of our Product Development organization, you will be responsible for ensuring the highest quality standards are met in our iGaming products and brands.The ideal candidate will have 2+ years of...
-
Technical Quality Assurance Manager
2 days ago
Stockholm, Stockholm, Sweden Brite AB Full timeAbout the RoleThis senior QA engineer position offers the opportunity to join our skilled QA team and contribute to shaping our QA strategy, toolset, and processes. As a key member of our team, you will be responsible for:Developing and implementing effective QA strategies in collaboration with the QA and Test domains.Providing expert guidance and support to...
-
Quality Assurance Expert for Digital Games
2 days ago
Stockholm, Stockholm, Sweden Paradox Development Studio AB Full timeAbout the RoleWe are seeking an experienced QA Analyst to join our team at Paradox Development Studio AB.In this role, you will play a crucial part in ensuring the high quality of our games, including Hearts of Iron IV and other new projects. You will work collaboratively with internal development teams and project leadership to develop and implement...
-
Quality Assurance Specialist
13 hours ago
Stockholm, Stockholm, Sweden SQA Services Full timeAt SQA Services, we are seeking a highly skilled Quality Assurance Specialist to join our global quality auditing team. As a Quality Assurance Specialist, you will be responsible for assuring quality in the supply chains of our clients in the life sciences area.This role involves working closely with our operations center to coordinate, prepare, execute, and...
-
Quality Assurance Coordinator
7 days ago
Stockholm, Stockholm, Sweden Alfa Laval Mid Europe GmbH Full timeWe're looking for a detail-oriented Quality Assurance CoordinatorJob Details:In this role, you'll be responsible for managing supplier development and improvement projects, ensuring suppliers meet required technical capabilities and delivery standards. You'll also collaborate with internal teams to ensure high-quality standards and continuous...
-
Quality Assurance Manager
2 days ago
Stockholm, Stockholm, Sweden TN Sweden Full timeAt TN Sweden, we are committed to delivering high-quality projects that meet our clients' needs.We are currently seeking a highly skilled Project Quality and Safety Manager to join our team in Stockholm.This is an exciting opportunity for a professional with experience in quality assurance, safety management, and project coordination to take on a challenging...