Beschreibung
CSV Coordinator/ QA IT Manager - Hessen - 6m ContractOptimus Life Sciences are working with an established German Consultancy to source a freelance CSV Manager to join them for a client project in Hessen. The role will last an initial 6 months and focus on the guidelines and requirements for the validation of computerized systems within the Pharmaceutical industry.
The role is due to start in early august, ideally interviews will take place on short notice. These will be via the phone and if possible as a face to face. For this role, German will be the daily working language - fluency in English would be a bonus.
For further details on the role, please contact Robert Marrett () to organise a call.
Role
- Responsible for ensuring that current quality systems are adhered to by all staff.
- Serves as the focal point for QA/QC and is responsible for the oversight and/or review of quality control data such as quality records, control charts, calibration records, documentation of corrective actions and other QA/QC data.
- Leads, plans, organizes and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, approved suppliers and validation of methods, systems & instrumentation.
- Ensures the plant is fully compliant with all relevant regulatory standards.
- Prepares monthly reports both to management and to the quality team summarizing quality activities.
- Provides guidance for validation and 21 CFR Part 11 implementation.
Requirements
- Understanding of regulatory requirements of the pharmaceutical industry for validation of computerized systems.
- Experience as validation coordinator and/or QA IT Manager.
- Experience with validation of IT systems, automation systems and laboratory systems.
- Excellent understanding of Annex 11, 21 CFR Part 11, and GAMP 5 requirements.