Senior Quality Assurance Operations Specialist

Vor 5 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Job Overview

We are seeking a highly skilled Senior Quality Assurance Operations Specialist to join our team. In this role, you will be responsible for implementing and maintaining quality processes in biopharmaceutical manufacturing.

About the Role

This is a key position within our organization that requires a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance production. You will work closely with cross-functional teams to ensure adherence to cGMP guidelines, develop and implement new processes, and improve existing ones.

Main Responsibilities:
  • Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept.
  • Implementation and Maintenance of Quality processes for Review / Approval of master batch records/ executed batch records.
  • Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance.
  • Review and approval of operational elements such as procedures and related documents including specifications.
  • Assist with continuous improvement initiatives related to quality documents and processes.
Key Qualifications:
  • Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.
  • 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.
  • Knowledge of pharmaceutical manufacturing processes with particular focus on biologic drug substance.
  • Fluent communication (oral and written) in German and English.
  • Experience in SAP and electronic MES (manufacturing execution system) is an asset.
About Gi Group SA

Gi Group SA is a leading provider of recruitment services in the pharmaceutical industry. We offer a range of solutions to help our clients find the best talent for their organizations.



  • Basel, Basel-Stadt, Schweiz Datalynx AG Vollzeit

    We are looking for a Senior Quality Assurance Specialist to join our team at Datalynx AG. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of quality in our analytical-pharmaceutical operations.About the RoleReview and approval of SOP's, protocols, reports, Certificate of Analysis, and other...


  • Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Job OverviewWe are seeking a skilled Packaging Quality Assurance Specialist to join our team in Switzerland. As a key member of the IMP Quality Clinical Packaging team, you will be responsible for ensuring the quality of Investigational Medicinal Products (IMPs) meets Health Authority requirements and Company Standards.Your primary focus will be on...


  • Basel, Basel-Stadt, Schweiz ITRIS One AG Vollzeit

    At ITRIS One AG, we're committed to delivering high-quality digital experiences for our clients. We're looking for a skilled Technical Quality Assurance Specialist to join our team and help us achieve this goal.About the RoleThe Senior Test Automation Development Engineer is responsible for ensuring the quality of our software products. This involves...


  • Basel, Basel-Stadt, Schweiz Coopers Group GmbH Vollzeit

    Coopers Group GmbH is seeking a skilled Pharmaceutical Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for reviewing and releasing critical documents.Key responsibilities include:Reviewing analytical methods, method validations, specifications, risk assessments, deviation reports and...


  • Basel, Basel-Stadt, Schweiz Hrmanagement-steinmann Vollzeit

    At Hrmanagement-steinmann, we are seeking a skilled Quality Assurance Specialist to join our team in Basel, Switzerland.The ideal candidate will have a completed apprenticeship in IT and experience with IT Service Management (ITSM) processes.You will be responsible for planning and executing migrations and rollouts of Windows clients and servers in the...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Job DescriptionClinical Packaging Specialists play a crucial role in ensuring the quality and compliance of pharmaceutical products. As a key member of our team, you will be responsible for supporting all quality-relevant packaging processes, collaborating with packaging operations and relevant interfaces on GMP topics, and partnering with stakeholders to...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    About the RoleWe are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team at Roche. As a key member of our quality control department, you will play a crucial role in ensuring the highest standards of quality and regulatory compliance.Main ResponsibilitiesSupport the Quality Control department with strategic guidance on...


  • Basel, Basel-Stadt, Schweiz Actalent Vollzeit

    Achieve excellence in quality assurance by joining our team as a Quality Assurance Manager. In this role, you will be responsible for ensuring the compliance and continuous improvement of GMP standards across all IMP production facilities.About the Role:The Synthetic Molecules IMP Quality Group is responsible for quality oversight of the Synthetic Molecules...


  • Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Job DescriptionAs a Medical Device Quality Assurance Specialist, you will play a crucial role in ensuring the quality and safety of medical devices at Roche. Your primary responsibility will be to support the Quality Control department in implementing efficient and high-quality analytical testing for medical devices.Key responsibilities include:Assessing the...


  • Basel, Basel-Stadt, Schweiz Helvetia Schweizerische Versicherungsgesellschaft AG Vollzeit

    Company Overview:">Jet Aviation has been a leading provider of flight services for over five decades. With a global presence and a team of dedicated professionals, we strive to perfect the art of flight. Our commitment to quality and safety is unwavering, and we are seeking a highly skilled individual to join our team as an Air Operations Quality...


  • Basel, Basel-Stadt, Schweiz CLEEVEN Vollzeit

    At CLEEVEN, we are seeking a Senior Operations Specialist to join our team in Basel. This individual will be responsible for leading a team of engineers, developing strategies for business growth, and ensuring the successful delivery of projects.About the Position:Leadership:Lead a team of engineers in delivering high-quality projects.Develop strategies for...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Quality Assurance Manager/Clinical PackagingAs an employee of the Quality Organisation, you will ensure compliance with and continuous improvement of GMP compliance of the production companies at the Basel site. The task of the Synthetic Molecules Quality Group includes in particular the quality oversight of the Synthetic Molecules Drug Substance and Drug...


  • Basel, Basel-Stadt, Schweiz General Dynamics Vollzeit

    Company OverviewJet Aviation is a leading provider of aircraft management, sales, charter, completions, defence, FBO, fixed and rotary wing maintenance, and staffing services.The company has been in operation since 1967 and has grown to employ over 4,000 people worldwide with locations in more than 50 countries.Jet Aviation's mission is to provide...


  • Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Quality Assurance ProfessionalWe are seeking an experienced Design Quality Partner to join our Product Development Quality operation. As a key member of our team, you will support software and hardware development of new medical devices. Your primary responsibility will be to ensure effective partnerships within Q&R and related functions, enabling project...


  • Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    Our client is a leading biopharmaceutical company dedicated to providing innovative treatments for rare diseases. To strengthen their Global Quality team, they are seeking an experienced Product Quality Lead (m / f / d) for a contract. This role will be split between leading a quality improvement project and managing product quality oversight for...


  • Basel, Basel-Stadt, Schweiz Talentify Vollzeit

    Job DescriptionTalentify is seeking a highly skilled Quality Assurance Manager to join our team.Main Responsibilities:Document Review and Approval: Conduct thorough reviews and approvals of analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports to ensure...


  • Basel, Basel-Stadt, Schweiz Beigene Vollzeit

    Beigene is seeking a highly skilled Pharmaceutical Quality Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance with regulatory requirements.ResponsibilitiesReview executed batch records and create certificates of packaging, ensuring accuracy...


  • Basel, Basel-Stadt, Schweiz CTC Vollzeit

    About the Role:Candidates are sought for a Senior Quality Assurance Manager position at CTC. This role involves leading laboratory activities and overseeing project portfolios.Key Responsibilities:- Manage a team of up to 3 direct reports.- Oversee a project portfolio of up to 4 small projects or 1-2 highly complex projects.- Ensure organization of...


  • Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Pharmaceutical Quality Assurance ManagerJob Summary:We are seeking a highly experienced Pharmaceutical Quality Assurance Manager to join our team at Coopers Group AG.About the Role:The Quality Assurance Manager will be responsible for ensuring compliance with and continuous improvement of GMP compliance of production companies at the Basel site.Key...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    About the RoleAt Lonza, we are committed to improving lives through innovative life sciences solutions. We are seeking an experienced Senior Director, Global Head MCC to lead our Sterility Assurance and Microbial Contamination Control (MCC) efforts globally.Key Responsibilities:Develop and implement proactive SA and MCC programs for Lonza's operations...