Quality Assurance Specialist

hace 3 semanas


Salamanca, España Merck Gruppe - Msd Sharp & Dohme A tiempo completo

Job Description
Join our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute to our mission of using leading-edge science to save and improve lives around the world.
Responsibilities
Ensure compliance with the Quality Systems in the vaccine manufacturing process.
Ensure compliance with GMP regulations, our company's Quality Manual, and regulatory requirements.
Review batch documentation of products manufactured by our company.
Perform the pre-UD (UD, Usage Decision) process for the release of products manufactured by our company to the market.
Support adherence to the product release plan manufactured by our company.
Manage Quality information and metrics.
Manage Quality Assurance (QA) documentation.
Create and maintain Quality master data in SAP.
Manage specifications.
Review and implement regulatory changes.
Quality member in product complaints.
Preparation and review of PQR (Product Quality Review).
Creation, review, and approval of deviations, CAPAs, and change controls.
Support as QA representative in the introduction or transfer of new products.
Support as QA representative in process validation.
Perform Quality Oversight.
Preparation, review, and approval of risk analysis.
Participation in external and internal audits.
Participation in continuous improvement projects.
Qualifications
University education in Health Sciences.
Relevant professional experience in the pharmaceutical sector (at least three years).
Advanced English.
Advanced knowledge of GMP regulations and regulatory requirements.
Demonstrated ability to analyze, solve problems, and communicate effectively (oral/written) in Spanish and English.
Experience in Quality Assurance (QA).
Knowledge of batch documentation review and approval processes by Quality.
Knowledge of product release processes by Quality.
Knowledge of Quality System tools: change controls, deviation management, out-of-specification results, CAPAs, claims.
Data management in SAP.
Demonstrable experience in participation in projects, transfers, and audits.
Preferred
Knowledge of manufacturing processes, equipment, and facilities in the pharmaceutical sector, especially in the manufacturing processes of biological and sterile products.
Knowledge of Quality Control (QC) tests.
Experience in risk management, statistical tools, and continuous improvement methodologies.

#J-18808-Ljbffr



  • Salamanca, España Merck Gruppe - Msd Sharp & Dohme A tiempo completo

    Job Description Join our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute...


  • Salamanca, España Merck Sharp & Dohme Corp. A tiempo completo

    Job DescriptionJoin our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute...


  • Salamanca, España Merck Gruppe - MSD Sharp & Dohme A tiempo completo

    Job Description Join our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process. This is an exciting opportunity to contribute...


  • Salamanca, Salamanca, España Cytognos A tiempo completo

    About the Role:We are seeking a skilled Software Quality Assurance Specialist to join our team at Cytognos. As a key member of our team, you will be responsible for ensuring the quality of our software applications.Key Responsibilities:Verify that software developments have been performed correctly and according to specifications and requirements.Maintain...


  • Salamanca, Salamanca, España Cytognos A tiempo completo

    Key Responsibilities:We are seeking a skilled Software Quality Assurance Specialist to verify that our application developments meet the required specifications and requirements. The ideal candidate will have a strong background in Java development and experience with testing phases, including unit tests, graphical interfaces, integration, and...


  • Salamanca, Salamanca, España Msd A tiempo completo

    **Overview of MSD:**Msd is a global leader in the development and manufacturing of pharmaceuticals, committed to delivering innovative solutions that improve human health. Our Salamanca facility plays a critical role in our operations, producing high-quality veterinary medicinal products that meet the highest standards of quality and regulatory...


  • Salamanca, Salamanca, España Merck Sharp & Dohme Corp. A tiempo completo

    **Job Overview:**Merck Sharp & Dohme Corp. is committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.**Salary:** $85,000 - $110,000 per year**Job Description:**As a Vaccine Quality Assurance Specialist at Merck Sharp & Dohme Corp., you will play a crucial role in ensuring the quality of...


  • Salamanca, Salamanca, España Mattamy Homes A tiempo completo

    About the OpportunityAt Mattamy Homes, a leading Canadian homebuilder, we're committed to delivering exceptional quality and customer satisfaction. We're seeking a skilled Quality Assurance Director to lead our Product Quality Team in ensuring that our residential construction projects meet the highest standards.Job SummaryThe Senior Manager, Quality...


  • Salamanca, Salamanca, España Msd A tiempo completo

    OverviewMsd, a renowned pharmaceutical company, is seeking a highly skilled Veterinary Medicinal Product Quality Assurance Specialist to join its team at the Salamanca facility. This pivotal role plays a crucial part in ensuring that our product quality activities comply with GMP regulations, corporate policies, and established regulatory...


  • Salamanca, España MSD A tiempo completo

    Join our company as a Quality Assurance Technician/Quality Systems. This role is an exciting opportunity to actively contribute to the supervision of Quality Management and compliance with regulations at our manufacturing division. We are looking for a highly motivated individual who will ensure that quality systems are aligned with regulations, support...


  • Salamanca, España Mattamy Homes A tiempo completo

    .Location: GTA Ontario – 5 days/week – 2 days in Etobicoke office, 3 days on various sites Company: Mattamy Homes Canada Division: Greater Toronto Urban (GTU) Employment Type: Full-Time Role: Senior Manager, Quality Assurance Reports to: Vice President, Business Process & Customer Experience When it comes to forward-thinking homebuilding and thoughtfully...


  • Salamanca-Madrid, España Astellas A tiempo completo

    At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.Delivering meaningful differences for...


  • Salamanca, España Mattamy Homes A tiempo completo

    Location: GTA Ontario – 5 days/week – 2 days in Etobicoke office, 3 days on various sites Company: Mattamy Homes Canada Division: Greater Toronto Urban (GTU) Employment Type: Full-Time Role: Senior Manager, Quality Assurance Reports to: Vice President, Business Process & Customer Experience When it comes to forward-thinking homebuilding and...


  • Salamanca, España Mattamy Homes A tiempo completo

    Location:GTA Ontario – 5 days/week – 2 days in Etobicoke office, 3 days on various sitesCompany:Mattamy Homes CanadaDivision:Greater Toronto Urban (GTU)Employment Type:Full-TimeRole:Senior Manager, Quality AssuranceReports to:Vice President, Business Process & Customer ExperienceWhen it comes to forward-thinking homebuilding and thoughtfully planned...


  • Salamanca, España Mattamy Homes A tiempo completo

    Location: GTA Ontario – 5 days/week – 2 days in Etobicoke office, 3 days on various sites Company: Mattamy Homes Canada Division: Greater Toronto Urban (GTU) Employment Type: Full-Time Role: Senior Manager, Quality Assurance Reports to: Vice President, Business Process & Customer Experience When it comes to forward-thinking...


  • Salamanca, España Mattamy Homes A tiempo completo

    .Location:GTA Ontario – 5 days/week – 2 days in Etobicoke office, 3 days on various sitesCompany:Mattamy Homes CanadaDivision:Greater Toronto Urban (GTU)Employment Type:Full-TimeRole:Senior Manager, Quality AssuranceReports to:Vice President, Business Process & Customer ExperienceWhen it comes to forward-thinking homebuilding and thoughtfully planned...


  • Salamanca, España Gilead Science A tiempo completo

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to...


  • Salamanca, Salamanca, España Mattamy Homes A tiempo completo

    About the RoleWe are seeking an experienced Quality Management Executive to join our team at Mattamy Homes Canada. As a key member of our leadership team, you will be responsible for leading the Product Quality Team and providing key support to the Construction Operations team during the build process.Key ResponsibilitiesManage the Product Quality team in...


  • Salamanca, Salamanca, España Mattamy Homes A tiempo completo

    OverviewMattamy Homes, a leading homebuilder in Canada, is seeking an exceptional Senior Manager, Product Quality to join its dynamic Greater Toronto Urban (GTU) division. As a key member of the team, you will be responsible for leading the Product Quality Team and providing critical support to the Construction Operations team during the build...


  • Salamanca, España Mattamy Homes A tiempo completo

    u00A0 u00A0 u00A0 u00A0 u00A0 Location: GTA Ontario u2013 5 days/week u2013 2 days in Etobicoke office, 3 days on various sites Company: Mattamy Homes Canada Division: Greater Toronto Urban (GTU) Employment Type: Full-Time Role: Senior Manager, Product Quality Reports to: Vice President, Business Process & Customer Experience u00A0 When it...