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QC Expert

Posted on Mar 19, 2020 by Harvey Nash IT Recruitment Switzerland

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

For our client in Basel we are looking for a AS&T QC Expert for CMOs for 8 months project

Description:

Job Title: AS&T QC Expert for CMOs

Duration: 13/04/2020 - 31/12/2020

Location: Basel

Workload: 100%

General Responsibilities:

  • Ensure that CMOs are using the correct Novartis specifications and methods
  • Write equivalence reports for Novartis and CMO testing monographs
  • Review testing methods where equivalence cannot be granted and provide smart solutions
  • Responsible for writing and coordinating Agile Change Requests AQWA (track wise) actions/deviations/quality events
  • Ensure that coordinated contact is maintained with other functions within Novartis also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations etc

Tasks within the organisation:

  • Supporting authoring and review of technical documents (registration common technical documents, method validation protocol/reports, risk assessments, technical health authority responses etc.)
  • Ensure testing monographs (TMs) for starting materials, chemical intermediates and drug substances (for transfers/launches only) are state of the art and with respect to technique and technology and in line with registration documentation. Support change control to upgrade testing monographs
  • Partner with QC and MS&T to support the product life cycle
  • Ensure that coordinated contact is maintained with other functions within Novartis also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc.
  • Support Launch and transfer Project QAMs regarding interpretation and review of analytical data/reports
  • Provide analytical support to ESO (chemicals), MS&T and DS release group as appropriate for starting materials, chemical intermediates and drug substances
  • Ensure that external supplier/CMOs are using the correct Novartis specifications and methods (where appropriate)

Tasks with external suppliers and contract manufacturing organisations (CMOs):

  • Participates and/or prepares cGMP audits of external contract laboratories and supplier/CMO laboratories, as required
  • Leads sourcing of new potential analytical contract laboratories
  • Review and approve validation protocols and reports across the external supply launch and transfer portfolio upon request from QAs and MS&T
  • Ensure the suitability of analytical specifications for Novartis materials from suppliers/CMOs. And support the implementation of internal release limits where applicable
  • Promotes good analytical data integrity practices and harmonisation of practices in external suppliers/CMOs. Review analytical reports to check for any data integrity issues versus copies of raw data if required. Participate in "on site" visits of supplier/CMO analytical laboratories as requested
  • Support technology transfer plans and protocols for analytical method transfers of launch and transfer materials
  • Support assessments of analytical change control records for acceptability. Define studies needed to support the changes. Initiate and manage change requests relating to specifications and analytical test methods Ensure analytical changes are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure
  • Interacts with the external supplier to guarantee suspect analytical result investigations are managed in agreement with Novartis standards and the right CAPA is implemented
  • Support external supplier qualification process. Responsible for follow up of supplier material status in SAND (supplier approval) for raw materials, chemical intermediates and launch/transfer DS, where applicable
  • Responsible for the AS&T/QC aspects of the external supplier assessments, (risk assessments, data integrity assessment etc.) and the identification of remediation plans and execution
  • Support site readiness for Health Authority inspections. Participate in audits of Contract labs or routine inspections of Contract Manufacturers/Suppliers on request
  • Review and approve stability protocols and reports across the external supply product portfolio. Interprets stability data, analyses trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, and packaging and transport categories. Provide corrective actions to address immerging stability issues
  • Ensure supplier/CMO analytical documentation for registration is complete and in a suitable format

Candidate Profile:

  • Education: Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
  • Languages: Fluent in English - spoken and written

Professional Experience & Skills

  • Working experience in Pharma (API): 3-5 years with strong analytical background (Testing methods for API analytics) - With very strong experience in API and analytics
  • At least 3 years experiences in managing and executing AS&T activities preferable in product and method transfers
  • Understanding of risk assessment and risk management
  • High learning agility and knowing of executing tasks in IT tools like Trackwise (AQWA), Subway, Agile desirable
  • Strategic thinking and sound knowledge of GMP guidelines (EU, US, ROW)
  • Project work experience preferred
  • Self-driven and pro-active person with strong team work and can do attitude

For further details please contact Aleksandra Kalicka: (see below)

Reference: 865697539

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