QA / QC Expert / no-633

4070 Basel (Klybeck)
Start Date: 
End Date: 
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For our customer located in Basel/Switzerland we are currently looking for (m/f) an QA / QC Expert

  • Type of placement:  12  months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area
  • Salary:  level 2, please ask us for the exact rate range 

(monthly all in salary levels in CHF,  level1= 5-10k , level2=10-15k,  level3= >15k)



Provide QA oversight on all external suppliers for BDSS. Manage supplier qualifications, supplier changes, and quality agreements. Assure compliance to cGMP standards is maintained for third party management at BDSS.



  • Responsible for initiating and driving supplier qualifications
  • Upgrade of supplier qualifications from clinical to commercial in scope of the BDSS going commercial project
  • Upgrade of raw materials and consumables from clinical to commercial in scope of the BDSS going commercial project
  • Oversight on all suppliers and raw materials used at BDSS
  • Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice
  • Manage and evaluate change notifications from external suppliers
  • Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties
  • Perform local implementation of Quality Manual and global procedures (gap assessment, local changes in SOPs...)
  • Manage projects, and provide QA support. May provide functional expertise in area of responsibility (supplier qualification).
  • Represent BTDM BDSS Quality in initiatives. Liaise with key stakeholders across NTO to identify compliance standardization needs.
  • Lead project related activities (e.g. development of new tools and processes).
  • Provide support to BTDM BDSS line functions in GMP compliance related issues in area of expertise.
  • Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc). Promote and enforce compliance to guidelines.



  • Supplier oversight and supplier approval rate
  • In accordance with BDSS objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections.
  • Act in accordance with our customer  standards, in particular ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
  • Maintain sound working relationships with partners and customers.
  • Feedback from other team members
  • Meet quality and timelines in all projects


  • Education: 

o Minimum: Basic degree in scientific or relevant discipline (BS or equivalent)
o Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)

  • Languages: 

o Fluent in English (oral and written) required; fluent in site-language desirable

  • Experience/Professional requirement: 

o At least 3 years of relevant experience.
o Strong ability to negotiate and communicate.
o Good team working skills
o Sound scientific, technical and regulatory knowledge.
o Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
o Good knowledge of drug development and drug substance production.
o Good organizational skills.
o Good and proven ability to analyze and evaluate GMP compliance.