QA Expert – Drug Development – 5890 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 pre-commercialized 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.