MSI Pharma are wokring with a global biotech to source an experienced Validation Specialist to join their team. The main responsibilities for this role is as follows:
· Participate in the qualification of analytical instruments in accordance with USP .
· Prepare equipment qualification documents, including user requirement specifications (URS), design qualification (DQ), risk assessments, IQ/OQ/PQ protocols and reports.
· Follow Good Documentation Practices (GDP) and data integrity standards, including 21 CFR Part 11.
· Prepare standard operating procedures (SOPs) for operation & maintenance of laboratory equipment and other procedures as needed.
· Oversee calibration, qualification, and validation of laboratory equipment by qualified external service providers.
· Minimum of 1 year experience working in an FDA-regulated biotechnology or pharmaceutical company is required.
· Familiar with FDA and EU GMP regulations.
· Familiar with instrument and equipment qualification/validation.
· Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
· Strong communication skills (written and verbal).
· Strong analytical and problem-solving ability.
· Hands-on approach, with a can do attitude.
· Ability to prioritise, demonstrating good time management skills.
· Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
· Self-motivated, with the ability to work proactively using own initiative.
· Committed to learning and development.
BSc or BA minimum