Validation and Compliance Manager - Computerized Systems

• 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.

The Validation and Compliance Manager must meet the following requirements:

• Master's degree in engineering, pharmacy, biochemistry, biotechnology or chemistry.


• Postgraduate degree in IT-Systems could be an additional asset.


• Understanding of SAP management.


• Minimum 2 years of work experience in computerized systems environment for pharmaceutical premises which are under the EU-GMP certification, preferably in the aseptic production lines for vials and pre-filled syringes.


• Significant experience in Qualification, R&D and project management.


• Proven experience in EU-GMP and US-FDA inspections


• Good understanding of Annex 11 and Annex 15 of EU-GMP.


• Soft Skills:


• Proven ability to plan resources and manage priorities to consistently deliver on time against tight project deadlines


• Ability to work independently and to solve problems.


• Ability to effectively and clearly communicate into English and Spanish- both written and verbal.


• Good computer literacy skills in MS Office package as well PDF edition for creation or records.


• Flexible mind for work in a multinational, multitask and multiteam environment.