Deputy Head of Quality Assurance GMP (m/f/d)

82152 Martinsried
22.04.2021

Daten dieser Anzeige

Job-ID: 021371256
Deputy Head of Quality Assurance GMP (m/f/d)

Coriolis Pharma Research GmbH

Germany

https://career.coriolis-pharma.com/stellenangebote/8212426/bewerbung?utm_campaign=jobware&utm_source=jobware&utm_medium=jobware

As Deputy Head (m/f/d) Quality Assurance GMP you will be jointly responsible for ensuring the operation, maintenance and continuous improvement of Coriolis Pharma's GMP-based Quality Management System (QMS). At our site in Martinsried you will support the further development of the GMP-based Quality Management System (QMS) of Coriolis Pharma. It is in your scope to ensure that the QM principles from Coriolis Pharma are applied and that the regulations within the GMP area are followed. This includes the following tasks: Maintaining and optimizing the quality management system Preparation, review and approval of controlled documents Review and approval of validation and qualification documentation, as well as analytical test results Preparation of and participation in regulatory inspections and customer audits Coordinate internal audit program, and plan and conduct self-inspections Management of training documentation and training database, as well as training execution Management of quality assurance agreements Archiving of documents Processing of deviations, change requests and OOS results Risk and CAPA management Technical consulting of the project teams in all GMP matters

Deputy Head of Quality Assurance GMP (m/f/d) About us   Coriolis Pharma, is a globally operating independent service provider for formulation research and development of (bio)pharmaceutical drugs (proteins, peptides, monoclonal antibodies, RNA/DNA etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio)pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals. Your Tasks   As Deputy Head (m/f/d) Quality Assurance GMP you will be jointly responsible for ensuring the operation, maintenance and continuous improvement of Coriolis Pharma's GMP-based Quality Management System (QMS). At our site in Martinsried you will support the further development of the GMP-based Quality Management System (QMS) of Coriolis Pharma. It is in your scope to ensure that the QM principles from Coriolis Pharma are applied and that the regulations within the GMP area are followed. This includes the following tasks:   Maintaining and optimizing the quality management system Preparation, review and approval of controlled documents Review and approval of validation and qualification documentation, as well as analytical test results Preparation of and participation in regulatory inspections and customer audits Coordinate internal audit program, and plan and conduct self-inspections Management of training documentation and training database, as well as training execution Management of quality assurance agreements Archiving of documents Processing of deviations, change requests and OOS results Risk and CAPA management Technical consulting of the project teams in all GMP matters Your Profile   Scientific degree (preferably pharmacy) Conscientious, structured, goal-oriented and independent way of working Several years of professional experience in GMP quality management in the pharmaceutical industry Confident handling of documentation in the GMP environment Organizational skills and assertiveness Very good MS Office skills (Excel, Word, Outlook) Good knowledge of GMP and relevant regulations (AMG; AMWHV, Pharm. Eur. ICH, USP, GAMP) Very good knowledge of German and English, both written and spoken What we offer   We offer you diversified and challenging areas of responsibilities in our innovative company. You'll become part of a highly motivated, interdisciplinary team to work and share ideas with. We actively support your personal development (technical, scientific and personal skills) especially by training on relevant techniques for characterization of biopharmaceuticals. Beyond that Coriolis offers a variety of benefits and team activities to its employees. Please, visit our website for further information: www.coriolis-pharma.com. Apply now Thomas Schwarzbauer Human Resources T: +49 89 417 760 235 Coriolis Pharma Research GmbH Fraunhoferstr. 18b 82152 Martinsried   At the moment there is no suitable job for you? Register for our job subscription.

Ingenieurwesen

Technische Berufe/ Fertigung/ Produktion

Projekt- und Produktmanagement/ Qualitätsmanagement

Pharma, Chemie, Med.-/ Biotechnologie

Unternehmensführung/ Management

Öffentlicher Dienst, Verwaltung, Verbände, Vereine

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

82152 Martinsried