Beschreibung
On behalf of one major client in the Pharma industry, Harvey Nash is currently looking for a Production Process Manager in Switzerland.
Project description
Provides support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements in terms of Validation Policies and Procedures are addressed Managing Complexity/Technical Accountability Serves as technical expert for the Validation process and responsibilities to ensure compliance Resolves & manages technical operational problems in area of expertise. Technical expert for the Validation process and responsible for compliance * Resolves & manages technical operational problems in area of expertise Suggest and sometimes may implement innovation and continuous improvement within the Validation process Implements initiatives in the Validation Process that will deliver customer value at lowest cost Manages relationships externally and internally Builds cross-functional and cross-departmental support, fostering overall effectiveness Ensure accuracy and maintenance of the Validation Master List Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate Ensure all validation activities and documents are authorized and appropriate compliance approval is gained Ensure compliance through assisting in audits Special Requirements
Knowledge of Manufacturing/Production processes (Pharma/Healthcare sector) knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry is a good asset Good understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations Working experience of validation computer systems for use in a FDA regulated environment Must be able to lead and give direction to Validation Projects and Teams. Experience to work in validated environments, GxP and 21 CFR part 11 Team player and excellent communication skills Ability to perform in distributed, virtual teams Project scope
Start: ASAP OR 01.06.13 End: 31.12.13 (extension very likely) Location: Solothurn (Switzerland) Interested? Then please send your complete CV (word documents preferred) or contact me directly. I am looking forward to receiving your application.
