Validation Specialist

3 days ago


South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Validation Specialist

Permanent Position

Walker Cole International is searching for a Validation Specialist to join a growing Cell & Gene Therapy company based in South East England.

**Responsibilities**:

- Plan, author and execute Validation activities within the framework of cGMP
- Work with validation contractors to support commissioning
- Manage the lifecyle of validation documentation
- A minimum of 2 years experience working with validation (does not need to be a purely Validation focussed or SME role)
- A minimum of 2 years experience working in a GMP-compliant environment
- DESIRABLE: experience of working within ATMPs, biologics or sterile environments

Quality Assurance | QA | Quality | GDP | Biopharmaceutical | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | Batch Review | Batch Release | QMS | Quality Management System | Documentation Management | Audit | MHRA | FDA | Good DistributionPractice | Cell and Gene Therapy | ATMP | Cell Therapy | Gene Therapy | PQS | Pharmaceutical Quality System | Good Documentation Practice | Operations | GMP | Good Manufacturing Practice | Manufacturing | Biopharmaceutical | Pharmaceutical | Biotechnology| CAPA | Corrective and Preventative Action | Quality | Quality Operations | Deviation | RCA | Root Cause Analysis | OOS | Out of Specification | OOT | Out of Trend I Manufacturing I cGMP I Current Good Manufacturing Practice I GxP I Validation I ManufacturingI OSD I Oral Solid Dose I Tablet I Capsule I Solid I Pharmaceutical I Biopharmaceutical I Process I Processes I Equipment I Cleaning I Cleaning Methodologies I Utilities I Facilities I Computer I Computer Systems I CSV I Computer Systems Validation I AnalyticalI Analytical Methods I VMP I Validation Master Plan I Audit I Commissioning I Qualification I Revalidation I Remediation I Requalification I Quality Control I Systems I



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