Validation Consultant

Nivelles , Wallonia, Belgium

Type: n/a

Category: Administration

Requirements: English
Company: Planet Pharma
Region: Nivelles , Wallonia

Planet Pharma are currently partnered with a leading biotechnology company who are at the forefront of innovation in developing life-saving treatments. Their commitment to excellence and patient care drives their mission to bring transformative therapies to global markets. They are seeking a highly skilled and experienced Validation Consultant to join their team

The Validation Consultant will be responsible for writing the software validation deliverables and initiate review and approval document lifecycles in EDMS aswell as ensuring the compliance with the methodology and SOPs and ensure the use of relevant tools.

Responsibilities:

• Ensure that the project validation deliverables are complete and consistent and delivered on time.
• Ensure that project-related issues and deviations are recorded.
• Assist in writing, reviewing Validation SOPs and templates.
• Assist in resolving Computerized System Validation compliance issues.
• Create and manage quality events such as change controls, deviations, CAPAs, etc.
• Ensure timely, open, and effective communication to relevant stakeholders.
• Ensure project timelines are followed, and potential issues are communicated.

General: (Must have)

• Experience working either in or near a biopharmaceutical medical or development. Sciences function, either within BIS and/or development sciences function.
• Experiences as Validation consultant for computer systems in a regulated industry.
• Understanding of the industry landscape and global regulatory requirements on data integrity.
• Excellent attention to detail and documentation.
• Demonstrated ability to work, effectively communicate, and influence at multiple levels within multidisciplinary organization.
• Can work autonomously, have a critical mind, have good communication skills.

Specific Skills: (Preferable)

• Experience with management of Study Clinical Data
• Experience in SAS Life Science Analytics Framework (e.g. implementation and / or operation of SAS tools, as well as the creation of the related documentation).

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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