* 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:
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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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