QC Equipment Officer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Working hours: Standard Working hours - Monday to Friday - 8.30am to 4.30pm

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:

This role requires you to operate within a matrix management system to deliver key responsibilities. You will be accountable for supporting the equipment team with the timely and complaint calibration, maintenance, and qualification of Laboratory Equipment within Quality Control.

Responsibilities:

• Assisting Equipment Specialists with qualification activities to agreed timelines, including reviewing of documentation, ensuring we can deliver to project timelines.
• Perform equipment qualifications for equipment including firmware-based equipment, for the full qualification lifecycle.
• Support and host contractors ensuring that induction activities are performed and understand emergency procedures and follow safe systems of work.
• Manage asset registration, complete equipment certification, and co-ordinate work orders, implementing department scheduling for the ongoing performance verification, calibration, maintenance, and other scheduled activities for the QC department, working alongside other departments and service providers, including supporting the maintenance contract renewals and purchases.
• Generate and prepare quality documentation e.g. Investigations, SOP’s, Work Instructions, and Change Controls.
• Support investigations and fault finding into issues impacting analytical equipment and carry out performance verification of equipment.
• Manage own time to ensure quality actions, plans, targets, training, investigation and instigation of EHS actions, 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 (PPI) initiatives 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

Minimum Requirements/Qualifications:

• Relevant science-based degree; e.g. Chemistry, Biology, Pharmacy or equivalent experience 2+ years’ working in a pharmaceutical QC function
• Technical experience, must have minimum 2 years’ and ‘hands-on’ knowledge working with analytical systems such as balances, HPLC, GC, and general laboratory equipment including extraction cabinets, pH meters, ovens, water systems
• Must be confident to perform presentations, and host external visitors and contractors
• 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