Consultys

Consultys  is a specialist LifeScience consulting firm. With more than 360 experts working in France, Belgium, Germany and Switzerland on major engineering and compliance projects for the world’s leading pharmaceutical, medical device and biotech companies. Consultys links operational compliance, quality, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.

Consultys Geneva, Geneve, Switzerland
21/10/2019
Full time
In your role as a Consultys Compliance Expert, you are supporting our local clients and team by: Roles and responsibilities: Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech) Advisory and support of application owners to build and maintain GxP conform systems Support and consulting during projects handling GxP critical computer systems Implementation of qualification / validation activities within projects of new and existing computer systems according to our client requirements Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity) Computer systems according to internal Software Development Lifecycle Performing internal and external CSV trainings Qualifications: University degree in Informatics, Quality, Engineering or another relevant discipline - At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems - Working knowledge of national and international regulations and standards, eg. GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11 - Analytical and structuRAIN working style; strong attention to detail - Ability to effectively work as part of a multidisciplinary, international team Hands-on personality, with flexibility and dedication to maximize our client's value - Good verbal and written communication skills in English, German language is a plus You can differentiate Consultys from the pack. Whether you are a graduate or an experienced professional, if you feel you would thrive in our environment, we would be pleased to hear from you.
Consultys Lausanne, VD, Switzerland
21/10/2019
Full time
In your role as a Consultys Compliance Expert, you are supporting our local clients and team by: Roles and responsibilities: Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech) Advisory and support of application owners to build and maintain GxP conform systems Support and consulting during projects handling GxP critical computer systems Implementation of qualification / validation activities within projects of new and exist- ing computer systems according to our client requirements Conception and implementation of Raw-Data-Handling systems and solutions (Data Integrity) Computer systems according to internal Software Development Lifecycle Performing internal and external CSV trainings Qualifications: University degree in Informatics, Quality, Engineering or another relevant discipline - At least 2-3 years of experience in validation of GxP relevant IT systems such as ERP, MES, LIMS or Quality Systems - Working knowledge of national and international regulations and standards, eg. GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11 - Analytical and structuRAIN working style; strong attention to detail - Ability to effectively work as part of a multidisciplinary, international team Hands-on personality, with flexibility and dedication to maximize our client's value - Good verbal and written communication skills in English, German language is a plus You can differentiate Consultys from the pack. Whether you are a graduate or an experienced professional, if you feel you would thrive in our environment, we would be pleased to hear from you.
Consultys Lausanne, VD, Switzerland
21/10/2019
Full time
Roles and responsibilities: Writing Quality risk management (QRM) concepts with the corresponding SOPs, templates and tools for GxP Engineering / Lab environments Support our team and Senior Experts in harmonization of (Global) Quality Management Systems Execute Gap Analyses of the Q-Manuals against relevant Guidelines and Regulations Developing and implementing QMS (Policies/SOPs) improvements of our clients Writing of Global Quality Standards and Review incl. correction of SOP landscapes Ensure complied GxP documentation systems (incl. IT systems) of our clients Conception and Implementation of Supplier Quality Agreements Handling of Change Control Requests, Non-Conformities and CAPAs, ensuring their adequate and timely closure from QA perspective Support tech transfer and analytical method transfer activities Qualifications: Master’s or Bachelor’s degree in Pharmacy, Bio-Engineering or another relevant life science discipline Preferably at least 1-2 years of experience in a GxP environment or regulatory agency, include direct contact with regulatory agencies Familiarity with Swiss and (if applicable) EU, U.S. (FDA) legislation procedures and guidelines governing pharmaceutical products; knowledge of the quality GxP framework Good understanding of IT systems and data modeling incl. process design (MS Visio, MS Office, SAP, etc.) Strong attention to detail; proven ability to successfully handle conflicting priorities Ability to communicate well verbally and in writing is essential Demonstrated diplomacy and assertive skills in dealing with internal and external parties A mature and disciplined approach to work is essential Pronounced client focus and business orientation Strong organizational and business planning skills Proficient use of MS Office suite and relevant database application Fluency in German and English is requiRAIN, French or Italian would be a plus Hands-on personality, with flexibility and dedication to maximize our client's value You can differentiate Consultys from the pack. Whether you are a graduate or an experienced professional, if you feel you would thrive in our environment, we would be pleased to hear from you.