QA Expert

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

QA Expert - Drug Development ADA


Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a
QA Expert - Drug Development for
1 year contract with high possibility of
extension based in
Basel,
Switzerland.


Main Responsibilities:

  • Manage all required activities to support the release of drug substances, drug products and intermediates for development or precommercialized products in portfolio sent worldwide including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls, this in close collaboration and quality oversight of CMOs
  • Drive all QA related topics and be the main QA liaison for partners collaboration for development activities.
  • Accountable for the compliance to Quality assurance standards during the design, development, manufacture, supply and control of drug substances, drug products and combination products.
  • Supervise the GMP/GDP Development QA group as assigned within the Quality Assurance group.
  • Responsible for the Quality assessment during supplier/CMO evaluation.
  • Lead issue resolution and QA review in area of expertise for CMC team as well as Supply chain stakeholders.
  • Lead initiatives to improve quality in the relevant area, internally or through CMOs.
  • Manage the investigations of complaints at CMO level and complete investigations review in given timelines.
  • Lead the implementation of relevant quality agreements and manage communication with QA peers from the partners' companies.
  • Drive resolution of QA related problems linked to the partnerships.
  • Notify management of potential quality and regulatory issues in close collaboration with CMOs.
  • Ensure a GMP/GDP compliant supply chain.
  • Ensure the qualification status of the GxP environment where applicable.
  • Writing, editing, assessing and approving Good Manufacturing/Distribution Practices and regulatory relevant documents related to quality systems as well as support and involvement in internal and external audits.
  • Support regulatory agency inspections in the scope of activities.
  • Support actively the organization in matters of regulatory requirements, technology and training.
  • Provide technical and compliance guidance on deviations, investigations, CAPAs, and change control.
  • Review, evaluate and approve deviations and CAPAs.
  • Provide guidance on the resolution of testing issues, discrepancies and Out of Specifications (OOS).
  • Monitor the efficiency of the pharmaceutical quality system (PQS), establish relevant KPIs to monitor the efficiency, define and implement improvements of the PQS when required.

Qualifications and Experience:

-
Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
:

  • Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree.
  • At least 10 years of experience in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control.
  • Proven experience related to Health Authorities inspection, risk assessment and CAPA management.
  • Thorough knowledge of manufacturing, both at development and commercial stages, and control of drug substances, drug products and combination products.
  • Several years of experience in leading people in cross functional teams.
  • Thorough knowledge of (c)GMP/GDP and relevant international regulatory requirements as well as ability to accurately interpret and implement Quality standards.
  • Strong interpersonal and influencing skills, ability to manage and lead people and a passion for coaching and personal development.
  • Ability to communicate clearly and professionally both verbally and in writing.
  • Fluent in English. French, German or Italian are an advantage.

  • QA Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    Takeda NeuchâtelSite de Production Biotech | Biotech Manufacturing SiteTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better...

  • QA Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

    Takeda NeuchâtelSite de Production Biotech | Biotech Manufacturing SiteTakeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better...

  • QA Expert

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Expert Compliance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Panda International Vollzeit

    QA Manager - CMO - Basel - Zurich:Location Basel, SwitzerlandBusiness Sector BiotechnologyJob ref 22212Published 11 days agoQuality Assurance Manager - SwitzerlandAre you an experienced QA professional in Biotech? Join our client in Northern Switzerland, a prominent leader in cell & gene therapy. As a Senior QA Manager, you'll play an important role in...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult Vollzeit

    Technical QA ManagerTechnical QA Manager (M/F/d) - GMP / Pharma / Qualification / Validation / CSVProjekt:For our client, a big pharmaceutical company in Basel we are looking for Technical QA Manager (M/F/d).Background:Tasks & Responsibilities: Running, maintaining and continuously improving Qualification/Validation activities including Computerized System...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

    Technical QA Manager (m/f/d) - Quality Management / Qualification/Validation / CSV of Small Molecules / Data Integrity / GMP/IMP/ English & GermanProject: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical QA Manager (m/f/d).Background:The IMP Quality Operations Unit Switzerland in Global Technical...

  • Quality Assurance Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Kelly Services (Schweiz) AG Vollzeit

    For a big pharmaceutical company in Basel we are looking for a Technical QA Manager Background:The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Technical QA ManagerYou will support the end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.You will be reponsible for running, maintaining and continuously improving...

  • Technical QA Manager

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    Start date: As soon as possibleDuration: 1 year/possible extensionWorkload: 100%Location: Basel, on-site Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in BaseSupport of implementation of DI...

  • Technical QA Manager

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    Start date: As soon as possibleDuration: 1 year/possible extensionWorkload: 100%Location: Basel, on-site Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in BaseSupport of implementation of DI...

  • Technical QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    For our client from the pharmaceutical industry in Basel, we are looking for a technical QA managerGeneral Information:- start date: asap- extension: possible- workplace: Basel- remote: on-site required, home office upon discussion- travel: noTasks & Responsibilities: QA supervision of qualification- and validation-activities for GMP-relevant equipment...

  • Technical QA Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Talentor Switzerland Vollzeit

    General Information:start date: asapextension: possibleworkplace: Baselremote: on-site required, home office upon discussiontravel: no Tasks & Responsibilities:QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within PTD...

  • Quality Systems Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • Quality Assurance Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It's reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you're a part...

  • QA Expert Compliance

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Audit Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Thermo Fisher Scientific Vollzeit

    As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • QA Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Mundipharma Vollzeit

    Support all Quality related activities in the Region Middle East & Africa and Europe Consumer Health. To carry out Quality Management system activities on behalf of IACS to ensure compliance to current GxP legislation Provide management, leadership and oversight of Quality Assurance activities for, third party contract manufacturers, packaging operations and...

  • Quality Assurance and Pharmacovigilance Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    COMPANYALTOGEN is a Swiss engineering and consulting company specialized in life sciences with expertise in pharmaceuticals, biotechnology, medical devices.With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.We surround ourselves with junior to expert level...