service ist unsere leidenschaft

siecon personalmanagement – service ist unsere Leidenschaft

 

Für unseren Kunden, ein angesehenes und international ausgerichtetes Pharmaunternehmen in Biberach / Riss , suchen wir Sie im Rahmen der Arbeitnehmerüberlassung als

Specialist (m/w/d) QA

zum schnellstmöglichen Eintritt.

Unser Kunde bietet Ihnen ein hochinteressantes Aufgabengebiet, eine umfangreiche Einarbeitung in die arbeitsplatzbezogenen Themen sowie die Möglichkeiten zur internen Weiterbildung. Es bieten sich Ihnen persönliche und fachliche Entwicklungsmöglichkeiten nebst einer Übernahmechance in das Kundenunternehmen.

The Specialist QA for External Deviations maintains oversight on external deviations initiated by external partners
andprocesses Deviations at the interface with external partners ensuring sound investigation and CAPA processes in
compliance with internal and external regulatory requirements. Furthermore, the Specialist QA supports the
maintenance of Supplier Qualification and Quality Assurance Agreements, including the follow-up of CAPAs.

Ihre Aufgaben sind:

· Process external deviations and OOX results initiated by external partners (CMO, CL, Service Providers) in
compliance with regulations and BI internal procedures.
· Enter information about external deviations / OOX results in the database
· Assess external deviations and coordinate the investigation and CAPA in alignment with the Team Member
Quality as needed
· Coordinate deviation / investigation related activities and present the results to the key personnel at BI
· Support and advice functional departments during processing of deviations, investigations and CAPAs
· Represent the interface between functional departments, pharmaceutical key personnel as well as subject
matter experts and external partners
· Contribute to the optimization and development of the process and the supporting IT system for Deviation /
Investigation / CAPA Management
· Present deviations during inspections
· Generate KPIs, overviews and trend reports related to external deviations
· Supports the qualification process of external service and material suppliers by contributing to the creation and
maintenance of Quality Assurance Agreements and collection of documents and performing data entry in the
corresponding electronic database.

Das bringen Sie mit:

· Bachelor or Master degree with focus on natural science (e.g. Pharmaceutics, Chemisty, Biology or
Biotechnology) or Professional Training with several years of experience in the pharmaceutical industry in a
GMP regulated area (e.g. Quality Assurance)
· Several years of experience in the pharmaceutical industry in a GMP regulated area
· Knowledge and hands-on experience gained in GMP regulated environments in pharmaceutical development
or production or quality control or quality assurance for 3-4 years.
· Experience in development and manufacture of pharmaceuticals, biopharmaceuticals or ATMPs would be
beneficial.
· Knowledge of international regulatory guidelines (US, EU, ICH) and quality standards for human
pharmaceuticals including respective development activities and data handling.
· Knowledge of quality and risk management tools would be beneficial.
· Well organized and structured working approach
· Good communication and presentation skills
· Fluency in written and spoken English and German.
· Proficient in the use of personal computers.

Finden Sie sich in dieser Stellenbeschreibung wieder? Ist dies der Fall freuen uns auf die Zusendung ihrer aussagekräftigen Bewerbungsunterlagen. Bitte senden Sie uns Ihre Unterlagen unter Angabe der oben angegebenen Referenznummer an info@siecon-pm.de.

Bei Rückfragen steht Ihnen Frau Andrea Siegler unter der Telefonnummer 07351 5876779 gerne zur Verfügung.

Dieses Stellenangebot haben wir für Sie am 04.08.2020 aktualisiert!