Validation and Compliance Manager - Computerized Systems
Barcelona, Cataluña, Spain
Pharmaceutical company with new manufacturing facility in Barcelona|High added value project and development opportunities
In the purpose of international expansion, a consolidated and well-established pharmaceutical company decided to open a new manufacturing facility and R&D premises in the area of Barcelona. The main activities will be focused on acting as a Contract Manufacturing Organisation (CMO) for aseptic filling of generic and biosimilar products. Through the R&D premises, the company will also take the responsibility for importing Final Dosage Forms (FDF) inside EU markets from other third countries.
The Validation and Compliance Manager will have the following requirements:
Development of IT QMS infrastructure and data integrity approach by use of electronic records, digital signatures, blocked excel sheets….
Leading the data integrity and qualification/validation of computerized systems according to Annex 11 of EU-GMP.
Participate in root cause analysis investigation and execution of CAPA's as part of OOS-OOT, Non-Conformities, Incidents, Complains under Warehouse and Computerized systems scope.
Leading software management support related to Quality Activities in cooperation with assigned Quality Management System Compliance Manager.
Leading and updating the integration of BMS (Building Management System), SAP, CCTV and Particles Size Monitoring software inside quality system.
Preparation of all needed SOPs, WI's and records evidence applied to Warehouse activities and computerized systems.
Establishes Key Performance Indicators and provides product status reporting to the site management on product quality and compliance risks with proposed solutions for improvement of the quality and compliance systems
Participate as an expert in software and warehouse premises for external and internal audits as well as for the inspections by regulatory authorities.
Active support in Qualification Activities, SAT/FAT/IOPQ, Validation applied to Software's and production, laboratory, warehouse and general core data center.
Coordinate supplier audits during the qualification and validation phase focused on Computerized Systems and Warehouse/Manufacturing/laboratory, if needed.
Participate as an expert in software and warehouse/manufacturing/laboratory premises for external and internal audits as well as for the inspections by regulatory authorities.
Conducting of concerned trainings to the new staff inside Software Systems department under the Quality Assurance scope.
Career opportunities and professional development.
Salary according to market and value of the candidate.
Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Engineering & Science and Technology.
Flexible work schedule.
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