Qc Equipment Specialist

4 weeks ago

Swindon, United Kingdom Thermo Fisher Scientific Full time

**Job Title**: QC Equipment Specialist

**Position Location**:Swindon

**Working Hours**: Mon-Fri 8:30am - 4:40pm

**Position Summary**:
As a team of Equipment specialists in QC, we are accountable for timely and calibration and qualification of Laboratory Equipment within Quality Control.

**Responsibilities**:

- Ensure QC equipment calibration and qualification activities are planned, coordinated and completed across the QC department in accordance with agreed timelines
- Writing & execution of protocols and reports (URS/DQ/IQ/OQ/PQ), organisation of qualification work into packages suitable for audit presentation
- Assisting in maintaining a safe working environment within the QC Laboratory
- Optimally collaborate and coordinate initiatives with other departments
- Generate and prepare quality documentation e.g. Investigations, SOP’s, and Change Controls
- Lead and/or support investigations and fault finding into issue impacting analytical equipment
- Act as Subject Matter Expert (SME) for the above with regulators / clients (i.e. key part of audits and inspections)
- Manage own time to ensure quality actions, plans, targets, training, and objectives are delivered within agreed timelines
- Ensure own work follows Good Manufacturing Practice (GMP), Data Integrity and Good Documentation Practice (GDocP)
- Identify and drive Practical Process Improvement initiatives (PPI) including undertaking /supporting Self-inspections, GEMBA walks, Kaizen, and Huddle meetings as relevant
- Undertake ad-hoc activities that may be required by the business
- Support and encourage a “Quality Culture” and company 4i values (Integrity, Intensity, Innovation, and Involvement) throughout QC

**EH&S**
- Understand emergency procedures and follow safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.

**Minimum Requirements/Qualifications**:

- Relevant science-based degree; e.g. Chemistry, Biology, Pharmacy or substantial experience working in a pharmaceutical QC function
- Substantial Technical experience, must have minimum 2 years’ and ‘hands-on’ knowledge working with calibration and qualification of analytical systems such as balances, HPLC, GC, Chromatography Data System (CDS) such as Waters Empower software, UV, IR with the ability to maintain & troubleshoot these systems
- Must be confident to perform presentations, facilitate meetings and training sessions
- Good technical writing skills
- Wants to learn and have a natural curiosity to understand systems and processes
- Ability to work in a fast-paced environment crucial

**Benefits**:
In addition to a competitive base salary, depending on experience, we offer an annual bonus plan, 25 days holiday + Bank Holidays + option to purchase additional holiday through our holiday purchase plan, Life Assurance, Private Health Insurance, Contributory Pension Plan plus a variety of other benefits that can be tailored to suit you

**About us**

When you’re part of Thermo Fisher Scientific, you’ll do meaningful work, and join a team that values performance, quality and innovation. As an ambitious member of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 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 we do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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