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Csv & Equipment Qualification Specialist
4 mesi fa
Are you a dynamic and open minded person?
We are looking for you
We are searching for a **Validation Specialist/CSV** here called **Industrial IT & Good Engineering Practices Specialist**.
Our client is a multinational pharma company, global leader in pain management.
The company, an expanding, structured international business, is characterized by state of the art technologies and a strong drive for innovation.
Each day you'll enjoy a variety of challenges, such as:
- Dynamic interaction with internal and external customers to drive innovation
- Be part of a multidisciplinary group dealing with utilities/equipment/computerized systems implementation with focus on validation
- Support digital roadmap implementation and engineering/production project
- Application of global engineering standards, best practices to the manufacturing sites
- Provide scientific engineering solutions to problems in Global Manufacturing with focus on operations excellence and KPI satisfaction
- Taking care of utilities/equipment/computerized Validation lifecycle (e2e)
- Support in managing the inventory of computerized systems of the plant, undertake an evaluation of the periodic risk and propose the action plan
- Ensure top-level helpdesk of ERP (i.e. SAP), MES, serialisation and/or computerized systems of competence
To make the most of this role and truly thrive, you should have:
- University degree in Biology/CTF/Pharmacy/Engineering/ computer science (IT) or comparable
- Technical professional with at least of 2/4 years' experience in Pharma or comparable
- Risk management, data management, data integrity knowledges
- Knowledge of ERP system-SAP/SAP HANA system is beneficial
- Knowledge of validation techniques (GMP; GAMP; WHO, CFR21 )
- OPEX problem solving techniques is beneficial
- Interpersonal understanding and communication skills
- Strategic thinker, outstanding collaborator and convincing communicator, who always keeps business benefits and quality in mind
- Fluency in business English
- Track record of managing multiple conflicting priorities and project
We offer:
- a contract with an hiring purpose in a constructive and stimulating workplace;
- specific training to consolidate role skills;
- pharmaceutical contract with 14 monthly salaries, production bonus, welfare, free internal canteen, smart working.