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IT Validation Specialist (Iceland)

Posted on 4.12.2018

The IT validation specialist is responsible for managing validation projects of GMP computer systems and qualification of IT infrastructure with GMP impact within Alvotech.

He/she must be able to work in accordance with GMP practices, conducting all activities in a compliant manner.
Willing to take on additional activities with little to no supervision. Contribute to continuous improvement of procedures and processes at Alvotech.
Responsible for performing the following:
• Manage validation projects of GMP computer systems and qualification of IT infrastructure with GMP impact.
• Responsible for validation deliverables and meet the business goal for go-live.
• Ensure continuous compliance validation status of computer systems and IT Infrastructure.
• Create and facilitates validation documents; including plans, specs, protocols, etc.
• Facilitates and performs periodic reviews.
• Advice on quality matters, and assistance for closing compliance gaps found in audits and inspections.
• Participate in a dialog with infrastructure administrators, application administrators and system owners or relevant stakeholders to secure and maintain validated computer systems and qualified IT infrastructure.
• Reports to the Alvotech Computer Systems & Validation Manager responsible and works closely with Alvotech project managers and business/process owners.

Essential functions:
• Generating qualification/validation documentation.
• Ensures fulfilment of maintaining validated/qualified status of IT systems.
• Initiating and supporting discrepancies.
• Actively involved in the preparations for regulatory inspections.
• Identifying required document changes and updating of quality documentation.
• Update and maintain validation SOP’s as applicable.
• Organize execution of protocols with users.
• Supporting change controls of relevant GMP computer systems.
• Initiating and leading change control.
• Supports user management for GMP applications.
• Be aware of and comply with Alvotech’s current EHS policies.
• Other tasks as agreed with manager.
• Initiative to suggest process and environment improvements to managers and colleagues as appropriate.

• Minimum of a BSc in a relevant scientific discipline and direct industry experience, or 3 years’ experience in Pharmaceutical or Biopharmaceutical sector

• Knowledge of GMP standards required.
• Knowledge of and experience with FDA and EMA regulatory requirements in GMP, 21 CFR Part 11 and EU GMP Annex 11, preferred.
• Knowledge of GAMP 5 and computer system validation preferred.
• Knowledge of key IT quality management processes, e.g. software engineering, quality management, change management, configuration management, risk assessment, test and auditing within the Pharmaceutical or Medical Device Industry preferred.
• An understanding of IT infrastructure.

Additional skills:
• Communication skills: Excellent written and verbal communication skills.
• Linguistic skills:  Fluent command of the English language, both written and verbal.
• Computer literacy:  Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel in addition to other computer skills required for an IT expert.
• Organisation and management skills:  Will be required to participate and make positive contribution to team meetings.  Responsible for individual performance management.
• GMP experience: Will be expected to work to and comply with the requirements of Alvotech QMS cGMP and good documentation practises and policies. Will participate in self inspections and regulatory inspections.
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