About this QA Validation Specialist role at Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION
Reports To: QA Validation Manager
Group/Division: Pharma Services Group/Clinical Trials Division
Position Location: Horsham
Number of Direct Reports: 0
Position Summary
As a QA Validation Specialist, you will be responsible for interacting with various departments to provide validation support to validate equipment, equipment systems and computer systems along with the critical utilities and facilities required for operations at the Horsham & Crawley Sites.
You will work as part of the QA Validation team to establish engineering specifications and requirements for implementation and procurement of commercial equipment. You will be responsible for ensuring site compliance and all vital activities are performed on time to keep all site validated systems in a validated state.
Key Responsibilities:
- To lead, coordinate, perform, author, and support validation/qualifications, reviews and change control activities including equipment, facilities, systems, cleaning, distribution and CSV
- To 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.
Experience, Knowledge & Skills:
- 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
How will you get here?
Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values.
Takes ownership, accepts responsibility for your actions and always make sound decisions with solid communication skills.
Demonstrate an adaptive and flexible work style shown to be effective working across varied types of clients, product types and front-line team members.
Ensure compliance with cGMP and training requirements are met in line with business need.