GMP QA Validation Specialist (CSV & Equipment)

Thermo Fisher Scientific Inc.; Washington; On-site; GBP 42,000 - 66,000; Full time

Job summary

Thermo Fisher Scientific Inc. in the UK seeks a QA Validation Specialist to support validation of equipment, systems and critical utilities at Horsham & Crawley sites.

You will interact across departments to ensure compliant, on-time validation activities within GMP framework. You will lead, coordinate and document qualification efforts (URS, SIA, VP, DQ, FAT/SAT, IQ/OQ/PQ, CSV, PV and VSR), work with engineering and operations, train staff, and maintain the site master plan with timely reports

Qualifications

• Relevant Pharmaceutical/GMP proven experience
• Previous experience in a validation/CSV role
• Knowledge of GMP legislation
• Experience dealing with regulatory authorities
• Excellent presentational and motivational skills
• Ability to establish effective working relationships and communicate effectively
• Ability to prioritise own workload to deliver personal and team objectives within set timeframes

Responsibilities

• Agree scope of validation/qualification activities in line with company and regulatory requirements
• Work closely with engineering and operations to write and perform qualification and validation documents including URS, SIA, VP, DQ, ), Factory Acceptance Testing (FAT, requiring some travel), Site Acceptance Testing (SAT), IQ, OQ, PQ, CSV, PV and VSR
• Provide support on validation-related issues and site systems/equipment, assisting in audits and inspections
• To champion validation activities and training material and carry out training in validation/qualification
• Ensure the schedule is maintained, reports are written on time, and related documents are current according to the site master plan
• Author SOPs related to validation activities and where required for projects
• Represent QA validation in cross-functional meetings/projects as needed
• Conduct root cause analysis and deviation resolution for validation exceptions
• Support related activities within validation and compliance as required by the Validation Manager
• Actively participate in departmental improvement programmes
• Conducts all activities in a safe and efficient manner
• Perform other relevant additional duties as requested by the QA Validation Manager in line with business needs.

Skills

QA Validation

GMP Compliance

CSV Validation

Regulatory Liaison

Documentation Writing

Tools

URS

SIA

VP

DQ

FAT

SAT

IQ

OQ

PQ

CSV

PV

VSR

Job description

Thermo Fisher Scientific Inc. in the UK seeks a QA Validation Specialist to support validation of equipment, systems and critical utilities at Horsham & Crawley sites.

You will interact across departments to ensure compliant, on-time validation activities within GMP framework. You will lead, coordinate and document qualification efforts (URS, SIA, VP, DQ, FAT/SAT, IQ/OQ/PQ, CSV, PV and VSR), work with engineering and operations, train staff, and maintain the site master plan with timely reports