In dieser Position übernimmst du die Qualitätsaufsicht im Mikrobiologielabor und unterstützt die QC-Abteilung bei der Einhaltung von GMP-Vorgaben. Du bist verantwortlich für die Überprüfung von Dokumenten, SOPs und Testmethoden und sorgst dafür, dass sowohl interne als auch externe Qualitätsrichtlinien eingehalten werden.
Anforderungen
- •Bachelor's degree in microbiology, chemistry, or related field
- •Sound experience in pharmaceutical industry
- •Strong analytical and microbiological knowledge
- •Experience with analytical method validations
- •Knowledge in physico-chemical testing is advantageous
- •Background in cGMP regulations
- •Profound knowledge in laboratory equipment qualification
- •Auditing experience with health authorities
- •Solution-oriented and team-minded
- •Structured, focused, and well-organized working attitude
- •Excellent verbal and written communication in English
- •German language knowledge is advantageous
Deine Aufgaben
- •Qualitätsaufsicht im QC-Mikrobiologielabor bieten
- •QA-Unterstützung und Beratung für die QC-Abteilung bereitstellen
- •GMP-relevante Dokumente kontrollieren und freigeben
- •SOPs, Testmethoden und Validierungsprotokolle überprüfen
- •Out-of-Specification-Ergebnisse genehmigen bei OOXs-Ereignissen
- •Abweichungen, Untersuchungen und CAPAs im QC überprüfen
- •SOPs im Fachgebiet schreiben oder überarbeiten
- •Compliance mit GMP bei Tests sicherstellen
- •QA-Unterstützung bei der Überprüfung roher QC-Daten bieten
- •Proben/Testergebnisse im LIMS freigeben und Analysezertifikate ausstellen
- •Interne und externe Qualitätsrichtlinien einhalten
- •Wachstumsprojekte im Qualitätsbereich stark unterstützen
- •Inspektionen und Audits nach Bedarf durchführen oder unterstützen
Original Beschreibung
# QA Expert for QC 80 - 100% (m/f/d)
**CH - Stein** | **Full time**
Key responsibilities:
* Provides guidance and quality oversight for (QC Microbiology) laboratory
* Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.
* Control and release of GMP relevant documents of the QC Review and approval of SOPs, analytical test methods, method transfer protocols/reports and method validation protocols/reports, issued by QC.
* QA supervision for OOXs events during investigation in QC: Review and approve Out-of-Specifications/-Expectations/-Trend results
* Cooperation, review and approval of deviations (DRs), Investigations (INV), changes (CRs) and CAPAs within QC (Microbiology)
* Write or revise SOPs in the area of expertise and be the owner of these documents.
* Ensures compliance with GMP in the areas of bioburden-, sterility- and stability- testing, as well as reference standards
* Support QA for QC raw data review, as deemed required
* Release of samples/test results in LIMS and issue Certificates of analysis
* Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
* Strongly support growth projects in quality department
* Perform/support inspections and audits as required.
Key requirements:
* Bachelor, Master degree or PhD in microbiology, chemistry, biotechnology, or related field.
* Sound experience in the pharmaceutical industry, preferably in a QC or QA function.
* Strong analytical and microbiological knowledge expertise and experiences with analytical method validations.
* Knowledge in physico-chemical testing is advantageous
* Background in cGMP regulations, including USP, European and Japanese Pharmacopoeia.
* Profound knowledge in laboratories/laboratory equipment qualification/validation.
* Auditing experience and experienced in the interaction with health authorities (FDA, Swissmedic, etc.).
* Solution-oriented and strongly team-minded. Ability to oversee project and routine operation execution to identify non-compliance from quality standards.
* Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
* Excellent verbal and written communication in English. German language knowledge is advantageous.