Validation Specialist

Hobson Prior are currently seeking for a Validation Specialist to join a fantastic biotech establishment on a permanent basis located in London. Our client is focused on creating solutions that might have the possibility of curing those who suffer from severe illnesses.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will handle a system for linked aberrations and change controls/
• The ideal candidate will plan, guide, assist with all facets of validations actions which involves Equipment, Process, Methods, Preparation of Annual reviews and Revalidation when needed.
• Evaluate and approve validation, qualification protocols and reports.
• Offer validation assistance to data integrity compliance examinations across the site.
• You will guarantee own work conforms to GxP, Data Integrity and Good Documentation Practice (GDP) and is assumed rendering to suitable quality documents.
• To guarantee successful procedures and equipment validation, you will, interface with external consultants and contractors.
• Any other assigned duties.

Key Skills:

• A motivated individual with the ability to resolve issues.
• Capable of managing various tasks simultaneously with the capacity to work within an ambitious, deadline-driven setting.
• An organised individual with the ability to be innovative.
• Communication skills both verbally and in writing.

Requirements:

• Educated to a degree level in a scientific, engineering, pharmaceutical validation field or similar.
• Fluency in the English language.
• A background in quality assurance working within a pharmaceutical or biotech setting in sterile manufacturing.
• Familiarity with offering validation technical assistance and oversight to validation and qualification actions and executing the ideas, legislations, regulations and needs linked to qualification and validation of sterile products, aseptic procedures, equipment and systems, which involves CSV, such as EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
• Expertise on cell culture-based manufacturing practices and needs and cellular and gene therapies would be advantageous to the role.
• Acquaintance with using risk examination tools which involves FMEA.
• Capable of balancing the needs of the business and the needs of regulatory challenges.
• Knowledge and experience in quality management.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.