Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
When we're part of Thermo Fisher Scientific, we do challenging work, and are part of a team that values performance, quality and innovation. As part of a successful, growing global organization we are encouraged to perform at our best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Position Summary:
As a QA Validation Specialist, you will be responsible for interacting with several 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.
Responsibilities:
- Provide support on Validation related issues and site systems/equipment, supporting audits and inspections with respect to validation/qualification queries
- To lead, coordinate, perform author, and support validation/qualifications, reviews and change control activities including equipment, facilities, systems, cleaning, distribution and CSV. Ensure the schedule is maintained, reports written on time according to the site master plan, and related documents kept current.
- To champion validation activities and training material and carry out training in validation/qualification.
- To agree scope of validation/qualification activities in line with company and regulatory requirements, and support audits and inspection with respect to validation/qualification activities.
- Author/approve SOPs related to validation/revalidation activities
- Represent QA validation in multi-functional meetings/projects as required
- Work closely with engineering perform Site Acceptance Testing (SAT), IQ, OQ and PQ activities and protocols.
- Conduct root cause analysis and deviation resolution for validation exceptions
- To support related activities within validation and compliance as required by the validation manager.
- Conducts all activities in a safe and efficient manner
- Actively participate in departmental improvement programmes.
Minimum Requirements/Qualifications:
- Relevant Pharmaceutical/GMP Proven experience
- Previous experience in validation/CSV role
- Knowledge of GMP legislation
- Experience in dealing with Local and Regulatory Authorities
- Excellent presentational & motivational skills
- Ability to establish effective working relationships and effective communicator