Beschreibung
QA Manager (f/m/d) - parenteral manufacturing /quality control /GMP / Text Analytics / Discrepancy Management/ CAPA/ Technical Change Management (Veeva Vault) /SAP/ MES (PMX) /LIMS / German & EnglishProject:
For our customer a big pharmaceutical company in Basel we are looking for a QA Manager.
Background:
The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality, Quality Systems and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland. The QA Manager will support other QA managers in their daily work, in order to enable them to participate in the preparation for the introduction of a new global operational supply management application. The person will collaborate as a QA manager in close partnership with all involved parties, mainly at the Clinical Supply Centre Parenterals and at the Quality Control laboratories.
The perfect candidate has min. a bachelor's degree in Pharmacy, Biology, Biochemistry, Chemistry, Life Science or equivalent and a sound Quality Assurance knowledge with experience in GMP compliance for sterile drug product manufacturing and quality control. This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility.
Tasks & Responsibilities:
* Acts as a delegate of the Swiss RP for IMPs
* Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular parenteral drug product batches).
* Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and change records and validation reports).
* Performs self-inspections in GMP plants and laboratories at Roche Basel.
Must Haves:
* BS/MS/PhD Degree in Pharmacy, Biology, Biochemistry, Chemistry, Life Science or equivalent
* Min. 3 years experience in activities around parenteral manufacturing and quality control
* Min. 3 years experience in a GMP regulated environment
* Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus
* Fluent in German and English min. B1
* Fast learner, strong team player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots
* Proven ability to work independently and in a team towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
Nice to Haves:
* Project management skills
* Proficient contribution to health authority inspections and internal GMP audit
Reference Nr.: 923301SDA
Role: QA Manager
Industrie: Pharma
Workplace: Basel
Pensum: : 80-100% (max 20% home office)
Start : ASAP (latest start date: 01.08.2024)
Duration: 18++
Deadline: 21.03.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.