Description
We are looking for a
Senior QA Specialist, QA Ops Microbiology NOVJP (m/f)
Reference: -en
Start: 01/18
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- As QA-Specialist you are responsible for all relevant microbiological quality assurance aspects of the manufacture and/or release of drug products, starting materials and utilities/water for NTO Solids Stein and NTO Solids Wehr.
- Support microbiological monitoring of the environment in non-sterile production facilities (air and surfaces) including water, detergents & disinfectants in time and in accordance to cGMP rules, QMs and SOPs (this task includes the planning of activities, the evaluation and the interpretation as well as the documentation and the reporting of findings; furthermore, it comprises the correct investigation, QA-decision and documentation of deviations as well as the training of production personnel with regard to hygiene)
- Support qualification/validation of clean rooms and equipment (this activity includes the elaboration of qualification/validation protocols and reports and it comprises trouble shooting and QA-decision in the case of deviations)
- Point of contact for operators, manufacturing personnel, process experts/facilitators, PU Head, TRD, project teams, in terms of general microbiological (GMP-)questions
- Release of drug products, starting materials and utilities/water for NTO Solids Stein, NTO Solids Wehr and ChemOps Production MMZ
- Decision on “critical” and “non-critical” microbiological deviations and approval of the respective microbiological risk assessment
- Ensure correct and timely preparation and dispatch of analysis certificates (CoAs); (in particular, special clarifications in case of problems)
- Participate in the preparation of audits and government inspections (e.g., assisting with the preparation of presentations, trends, evaluations), as well as answering queries and providing information during inspections
- Writing/review/approval of all relevant SOPs
- Providing biological and microbiological services and QA support for global Novartis functions as TechOps and Development
Your qualifications
- (Technical) university/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent
- Fluency in German (spoken/written); fluency in English (spoken/written)
- Biological/microbiological analytics or diagnostics experience, including growth properties of micro-organisms and culture media preparation; quality control/ assurance in pharmaceutical industry or biotechnology, especially with regard to environmental monitoring and cleanliness zones
Skills:
- Quality manager