Compliance Consultant Manager

268 Compliance Consultant Manager

Europe

Remote work possible

IT
Permanent contract

To support our customers, Product Life Groupe Digital is searching for a Quality, Validation and Compliance Consultant/Senior Consultant to support computerised system validation and compliance work within the Pharma, Biotech, and Medical Device Industries.

It is essential that you have knowledge and experience from projects that use the risk-based approach, V-Model, Agile methodologies and GxP. The computerised system validations will span from pure IT to laboratory equipment and pharmaceutical production equipment across all GxPs

Furthermore, the job is expected to be executed in accordance with internal and international guidance such as GAMP.

As Quality, Validation and Compliance Consultant/Senior Consultant you are expected to:

• Review Computer Systems/Software Validation and Data Integrity Procedures to ensure that current regulatory compliance.
• Effectively execute Computerised System Validation (CSV) and Data Integrity (DI) programmes / projects in accordance with client requirements, regulatory requirements, and industry best practices.
• Deliver programmes / projects / work packages in accordance with agreed plans to the satisfaction of customers.
• Identify & mitigate CSV and DI risks
• Prepare and deliver CSV deliverables associated to activities, including but not limited to supplier assessment, Validation Planning and Reporting, Requirements Management, Design Verification, Traceability, Lifecycle Risk Management, all aspects of Testing phases, Data Migration.
• Prepare and deliver Operational Controls, e.g., Change control, configuration management, incident management, deviation management, CAPA, Periodic Review, etc
• Author SOPs and Work Instructions compliance of IT systems.
• Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle.
• Identify and mitigate data integrity issues and threats using critical thinking
• Be involved in DI programmes addressing all aspects of culture, behaviours, technologies, and processes.
• Use a range of DI tools including GEMBA, maturity assessment, gap analysis, data analytics

You will either work alone and together with the client ensure the right level of compliance in accordance with the client quality management system and GAMP 5 guidelines.

You will be coordinating and communicating independently with stakeholders and we expect this is done in a proactive and service-minded way.

To be successful in the role of Quality, Validation and Compliance Consultant/Senior Consultant, you will be expected to have:

• A bachelor's degree or higher.
• 10-15 years of experience within the Pharmaceutical, Biotech or Medical Device Industries, as well as experience with test and validation.
• Experience of other regulated, legal requirements would be beneficial including Data Privacy, Sarbanes Oxley would be beneficial
• Experience in a variety of computerised systems, applications and technologies including: Clinical systems (clinical trial management systems, eCTD, TMF, eCOA, Adverse Event Reporting, etc)
• Understanding of global regulatory requirements / guidance pertaining to computerised system validation e.g., US FDA 21 CFR Part 11; Electronic Records and Electronic Signatures, European Annex 11 Computerised Systems, PIC/S
• Understanding of global regulatory requirements / guidance relating to Data Integrity, MHRA, US FDA, WHO
• Understanding of industry good practices e.g., ISPE GAMP Guidelines and Good Practice Guides
• An attentive and detail-oriented approach, as well as the ability to independently resolve a variety of issues without close supervision.
• Good organisational and planning skills.
• The ability to work collaboratively and as part of a team.
• Excellent French and English communication skills (verbal, written, and interpersonal).

268 Compliance Consultant Manager