Clinical trial manager Work, Jobs in Haywards Heath, Wsx (with Salaries)

QA Validation Specialist
Thermo Fisher Scientific —Horsham
- Full-time
- Travel
- Communication skills
11d
Senior Quality Compliance Specialist
Thermo Fisher Scientific —Horsham
- Full-time
- Continuous improvement
- In-person
- Communication skills
10d
Client Services Project Manager Packaging
Thermo Fisher Scientific —Horsham
- Full-time
- Computer literacy
- Travel
- Organisational skills
3d
Area Business Manager - Southwest England & Wales
BD —Crawley
- £43,300 - £66,025 a year
- Weekend availability
- Sales
- IT
- In-person
Senior Manager, Operational Excellence (PPI)
Thermo Fisher Scientific —Horsham
- Full-time
- Engineering
- Bachelor's degree
- Continuous improvement

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QA Validation Specialist

Thermo Fisher Scientific -
Horsham

Apply Now

Job details

Full-time
11 days ago

Qualifications

Non-conformance investigation
Quality management change control procedures
Internal department liaison
SIA
Root cause analysis
Communication skills

Full job description

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.

Apply Now

Refine Your Search

clinical trial manager jobs in haywards heath, wsx

QA Validation Specialist

Senior Quality Compliance Specialist

Client Services Project Manager Packaging

Area Business Manager - Southwest England & Wales

Senior Manager, Operational Excellence (PPI)

Other jobs to consider

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