QA for QC Expert, Basel everyone
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Job Location:
Basel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
About Us
ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development manufacture and testing of tomorrows medicines. We support our clients in developing differentiated stable usable and safe injectable treatments for patients.
Your mission
We are seeking a highly motivatedQA for QC Expert to join our this role you will play a pivotal part in ensuring the highest quality standards for our drug products by providing dedicated quality oversight of our QC operations. This position offers a unique opportunity to contribute to the successful operation and compliance of our analytical laboratories.
Purpose
Your primary mission is to ensure that all laboratory testing analytical methods and data management activities are performed in strict compliance with GMP data integrity principles and approved procedures. By providing quality oversight of QC operationsincluding method validation instrument qualification and sample managementyou will ensure the reliability of test results through independent verification and risk-based controls ultimately protecting the integrity of product release decisions.
Key Responsibilities & Accountabilities
Purpose
Your primary mission is to ensure that all laboratory testing analytical methods and data management activities are performed in strict compliance with GMP data integrity principles and approved procedures. By providing quality oversight of QC operationsincluding method validation instrument qualification and sample managementyou will ensure the reliability of test results through independent verification and risk-based controls ultimately protecting the integrity of product release decisions.
Key Responsibilities & Accountabilities
- Method & Equipment Oversight: Lead the quality oversight for analytical method validation and equipment CQV (Commissioning Qualification and Verification) and lifecycle management.
- GMP Documentation & Review: Review and approve GMP documentation including material specifications analytical records QC results and CoA/TSE/BSE statements.
- Operational Quality Support: Perform regular GMP walks and provide on-floor oversight for sampling transport and general QC operations.
- Material Management: Manage material labels and ERP material status (excluding Drug Product) and handle the release of materials.
- Systems & Administration: Act as the MODA administrator and oversee sampling plans and APS (Aseptic Process Simulation) quality requirements.
- Quality Systems Management: Drive the management of Deviations CAPAs and Change Controls within the QC environment and support laboratory investigations.
Your profile
We are looking for someone with:
- Education: A Masters degree in science (Biology Microbiology Pharmacy or similar).
- Technical Experience: Proven experience in a QA role within a GMP-regulated environment for drug product manufacturing or testing.
- Specialized Knowledge: Strong understanding of QC operations analytical methods and data integrity principles. Experience in microbiology is a plus.
- Language Skills: Fluency in both spoken and written English is required.
- Professional Attributes: An independent and efficient team player who thrives in interdisciplinary collaboration and demonstrates a high degree of flexibility in problem-solving.
- Mindset: A proactive approach to contributing ideas and a strong willingness to take on responsibilities.
Why us
We offer a dynamic environment where you can contribute meaningfully collaborate with exceptional minds and unlock your full potential.
Heres what sets ten23 apart:
Heres what sets ten23 apart:
- A valuable and impactful career development opportunity in an inspiring environment
- Flexible working arrangements and environment with an open culture and diverse workforce
- The opportunity to work with and learn from highly qualified and experienced employees
- Our learning and self-developing culture offers a wide range of training options
- Competitive pension fund plan annual bonus and other financial and non-financial benefit
Contact
For more information and clarification please connect with Amrith () from our Talent team!
About us
While most applicants fall short of 100% qualifications we embrace diverse perspectives and encourage applications from all qualified candidates regardless of background. Women & underrepresented groups we see you!
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23
Join Us & Make a Difference! ten23 champions equal opportunity and is committed to diversity and inclusion.
Learn about ten23
Key Skills
- Digital Marketing
- Marketing
- Google Analytics
- Growing Experience
- Conversion Optimization
- Google AdWords
- Hybris
- Magento
- Account Management
- SEO
- E-Commerce
- Analytics
About Company
The partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines.
