Validation Specialist

4 weeks ago

London, United Kingdom Life Science People Full time
Job Description

​​​​We are currently partnered with an innovative Biotech in London, in their search for an experienced Validation Specialist to support GMP Manufacturing activities and ensure compliance with regards to the Validation program.


Major Activities

• Reviewing and approving external validation documents.

• Writing of validation documents 10/O0/PQ.

• Overseeing the execution of validation protocols.

• Completion of validation summary reports.

• Working closely with the Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification reports and the effective closure of quality records, as well as the completion of CAPAs and non­ conformances generated during validation/qualification activities.

• Assisting system owners with system/equipment URS and DQ documents and using a risk-based approach to determine the appropriate validation requirements.

• Managing validation reviews, re-qualifications and revalidations to ensure maintenance of the 'validated state' and ongoing GMP compliance.

• Assist with CSV and GAMP compliance where required.


Key Job Competencies

• Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations.

• Leadership - exhibits confidence in self and others.

• Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.

• Planning/Organising - prioritises and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives.

• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.

• Innovation - meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.

• Oral Communication - speaks clearly; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.

• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

• Practical skills - able to carry out validation/re-qualification tasks.

• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures

• Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken

• Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state


Job Responsibilities

• Completion of Experiments within provided budget & Timelines

• Support the development of the emerging R&D wet lab facility

• Assist in the performance of routine maintenance of the Lab


Job Background

• PhD degree in biochemistry or biology with experience in neurosciences; or

• MSc degree in biological discipline or equivalent and 2 years of academic/ biotech industry experience in molecular biology work, process development; or

• BSc degree in biological discipline or equivalent and 4 years of academic/ biotech industry experience in molecular biology work, process development;

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