Quality Assurance Project Manager (m/f/d)

61440 Oberursel
29.11.2019

Daten dieser Anzeige

Job-ID: 011704547
Quality Assurance Project Manager (m/f/d)

Fresenius Kabi Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=5482169

The position holder needs to provide current GXP support and advice (as based on suitable requirements, guidelines and FK standards) to the local QA, QC and plant teams in order to close possible compliance gaps in the laboratory or production and to further enhance and develop local skills and knowledge in that area Wherever possible the approach needs to be «hands on» and any documentation needed should be prepared together with the plants for closing gaps, to maximize a knowledge transfer from the position holder to the plant staff and increase knowledge at the plant Partly the assessments need to be done in audit/inspection style to verify laboratories and production areas comply to GxP standards and are ready for authority inspections Additionally tasks related to the overall Quality Management System of Fresenius Kabi might be applicable as follows: Participant in global quality system harmonization groups Issue and review global SOPs/Guiding Documents/Working Instructions Support in supplier audits Assure that the global SOPs/Guiding Documents/Working Instructions in regard to Validation and Laboratory systems are implemented in the plants/organizations Prepare plants for authority audits, performance of pre-audits and support during audits where applicable Running harmonization projects within QA, QC, Production areas Summary and analysis of quality metrics, preparation of review of quality metrics with management of organizations and follow-up with related works Recognize and track new developments in sterile manufacturing and propose quality improvement initiatives to Plant Management & Plant QA Preparation or Revision of Quality Management documents Analysis and implementation of guidelines (GMP, ICH, ISO, etc.) and national and international legislation applicable to the work done in relevant role Execution of Quality initiatives, which are started by the Competence Centers of the Pharmaceuticals Division

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Quality Assurance Project Manager (m/f/d) The role belongs to the Business Unit Parenteral Nutrition, Ketoanalogues and Standard I.V. Fluids Europe, Quality Assurance Europe,  with the target of  harmonization and development of the Quality Standards in place in all of the 5 Manufaturing plants in scope. The plants are manufacturing sterile liquids and are located in Europe (Germany, Poland, France, Spain and Italy),  with FDA, EMA and RoW Pharma as well as ISO 13485 regulations to comply with. The role will work in close cooperation with the Plant QA Managers as well as with the Senior Director QA Europe, to whom the role reports to. The Manager Quality Assurance & Projects, as part of the Corporate Organization, participates to all the global initiatives in place inside Fresenius Kabi and is deploying them in the relevant plants. Project Manager provides the local QA and Operations teams knowledge, advice and «hands on» support to improve the Q system, close potential compliance gaps and harmonize procedures and approaches between the sites. More The role belongs to the Business Unit Parenteral Nutrition, Ketoanalogues and Standard I.V. Fluids Europe, Quality Assurance Europe,  with the target of  harmonization and development of the Quality Standards in place in all of the 5 Manufaturing plants in scope. The plants are manufacturing sterile liquids and are located in Europe (Germany, Poland, France, Spain and Italy),  with FDA, EMA and RoW Pharma as well as ISO 13485 regulations to comply with. The role will work in close cooperation with the Plant QA Managers as well as with the Senior Director QA Europe, to whom the role reports to. The Manager Quality Assurance & Projects, as part of the Corporate Organization, participates to all the global initiatives in place inside Fresenius Kabi and is deploying them in the relevant plants. Project Manager provides the local QA and Operations teams knowledge, advice and «hands on» support to improve the Q system, close potential compliance gaps and harmonize procedures and approaches between the sites. Your assignments The job includes the following tasks: The position holder needs to provide current GXP support and advice (as based on suitable requirements, guidelines and FK standards) to the local QA, QC and plant teams in order to close possible compliance gaps in the laboratory or production and to further enhance and develop local skills and knowledge in that area Wherever possible the approach needs to be «hands on» and any documentation needed should be prepared together with the plants for closing gaps, to maximize a knowledge transfer from the position holder to the plant staff and increase knowledge at the plant Partly the assessments need to be done in audit/inspection style to verify laboratories and production areas comply to GxP standards and are ready for authority inspections Additionally tasks related to the overall Quality Management System of Fresenius Kabi might be applicable as follows: Participant in global quality system harmonization groups Issue and review global SOPs/Guiding Documents/Working Instructions Support in supplier audits Assure that the global SOPs/Guiding Documents/Working Instructions in regard to Validation and Laboratory systems are implemented in the plants/organizations Prepare plants for authority audits, performance of pre-audits and support during audits where applicable Running harmonization projects within QA, QC, Production areas Summary and analysis of quality metrics, preparation of review of quality metrics with management of organizations and follow-up with related works Recognize and track new developments in sterile manufacturing and propose quality improvement initiatives to Plant Management & Plant QA Preparation or Revision of Quality Management documents Analysis and implementation of guidelines (GMP, ICH, ISO, etc.) and national and international legislation applicable to the work done in relevant role Execution of Quality initiatives, which are started by the Competence Centers of the Pharmaceuticals Division Your profile Frequent travel and on-site support of plants The overall travel for the position holder is less than 50% overall and based in Europe, with a predominant amount of time spent in the german plant No permanent re-location or change of legal unit necessary Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education At least 2 years of experience in the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, EU GMP, WHO GMP, CFR210/211, ISO 13485 and ISO 9001 and other relevant standards Experience from GMP inspections/audits Very good English skills, German is preferred as well being Friedberg the biggest plant leadership, integrity, communication, proactivity and self organization Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Project Management, Other, Quality Management / Environment Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 35116 About Fresenius Career with a purpose: Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Teresa Martin Fresenius Kabi Deutschland GmbH Bad Homburg Ref. number: 35116 fresenius-kabi.com Career level: Professional Experienced Job category: Project Management, Other, Quality Management / Environment Working condition: Permanent contract / Full-time Business segment: Fresenius Kabi Location: Oberursel / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Sonstige Branchen

Medizintechnik/ Optik

Projektleitung/ Stabstelle/ Spezialist

Vollzeit

61440 Oberursel