CSV Specialist - Top Pharmaceutical Company
On behalf of one of the most recognisable names within the pharmaceutical industry, we are looking to speak with candidates, who are looking for the next step in their career. This is a 12 months contract role, with a top 10 pharma company, something that can add a significant amount of value to your profile and allow you to grow at an accelerated rate.
The role of MES Validation/SDLC lead provides leadership and direction to MES project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV).
- Defines the Global MES Validation approach and SDLC management
- Creates and maintains the global validation and SDLC templates
- Ensures project teams follow global validation guidelines & approach
- Ensure adherence to Computerized Systems Validation procedures/standards
- Assessments / Reviews of essential QA documents
- Support generation and maintenance for set of global URS elements (library) together with GE MES MBR lead and SPOC's from sites
- Establish and maintain Validation approach for MBRs based on Werum's PAS-X and Siemens Simatic MES platform together with MBR experts and Quality functions from sites
- Lead and drive community of MBR Validation experts (CoP; community of practice) to achieve harmonized validation approach of MBR's across sites and business units
- Support site MBR experts in validation of site specific MBRs
- Oversee the validation activities for the build of a new Global MES development and validation environment to enable center led qualifications of the application, architecture, vendor patches, upgrades, system interfaces, etc.
- Collate all MES SDLC documentation from all installation and the vendor to create global center led system SDLC documentation
- Partner with the Quality System Representative to ensure the Global MES environment and all associated SDLC docs and SOPs put us in a state of compliance.
- Develop training packages for operation support
- Support data integrity program definition and execution with regards to MES progam
- Ensure the adherence to cGxP and EHS regulations and guidelines corresponding to automation systems.
- Demonstrated competency in validation of complex manufacturing electronic batch record and integration of MES with business and automation systems
- Ability to work on his/her own on solutions incl. planning and organization
- High communication skills, analytical mind-set.
- Proficient at building relationships and a highly collaborative working style
- Education (minimum) Masters' degree in Pharmaceutical Sciences, Chemistry, Electrical Engineering, Information Technology or related Engineering/Technical field
- Languages Business fluent proficiency in English (written and oral) ,
- Know how in Computer System Validation (CSV), data integrity and cyber security
- Change management skills & experience
- Pharmaceutical industry knowledge is essential
Call me, Alex Manea, at NonStop Recruitment now for a confidential conversation. Contact me on A.Manea@nonstop-recruitment.com or : +44 207 234 0550, please send your CV in word format OR if this does not sound like the opportunity for you, but you are aprofessional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, USA, Romania, Luxembourg and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover