Quality Product & Project Lead

at  Thermo Fisher Scientific

POSITION SUMMARY:

The Quality Product & Project Lead (QPPL) role supports the Senior QPL and QA Operations Manager to drive and be responsible for new product introduction and continuous improvement initiatives from project phase (equipment and process validation) to commercialisation at our Swindon facility.
The role then requires continued support of the product through its whole lifecycle. The role is a hands-on quality role that has the responsibility to ensure GMP compliance is maintained & provides a single point of contact for the wider project team and the client ensuring consistency of support and clear reporting and support pathways.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Minimum Science based degree
• Substantial experience working in or directly supporting manufacturing within a drug product manufacturing site. Steriles manufacturing experience is vital.
• A solid understanding and demonstrated application of the principles and guidelines for GMP as set out in Eudralex Volume 4 and U.S. 21CFR part 210/211
• Secure decision making abilities. Holds self and others accountable in achieving goals.
• Strong leadership skills with good collaboration, communication and problem solving skills. (Experience of developing and influencing business strategy is desirable.)
• Excellent written and verbal communication skills to internal and external partners.
• Desire to learn and a natural curiosity to understand systems and processes
• Ability to work in a fast paced, matrix environment is crucial
• Capable of working to challenging timelines and able to prioritize multiple tasks but with the flexibility to meet changing needs and priorities of the business.

ABOUT US:

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part 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.
At Thermo Fisher Scientific, each one of our 130,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer

• Supports delivery of NPI projects. Works with management to resolve project issues and resource constraints within the team.
• To ensure new products, equipment and processes are effectively introduced to internal & external standards.
• Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing and operations support.
• Lead completion of GMP documentation to the required standard and timescales, to ensure timely and efficient service for our internal and external clients.
• Work alongside QA Officers, Senior QA Officers and QA Shift Leads to help ensure correct decisions are made within Operations such that compliance and product quality are not compromised
• Provide a single primary point of contact for the client(s) on quality related topics. Alongside Business Management, leads the receipt of client requests and the flow of information back to the client.
• Ensures resolution of significant quality issues with the client through coordination and the collaboration of internal functional resources to identify, propose and carry out an efficient plan to settle the issue, while protecting product quality and patients safety.
• Supports and/or performs the timely review and approval of deviations/ out of specifications /out of trends, Validation protocols / Report, CAPA, effectiveness checks, change controls, technical transfers, batch records, QC records, (etc.).
• To act as a QA representative in risk management/ improvement initiatives, Regulatory Inspections and audits (e.g. client and corporate)
• Generates quality metrics – RFT, Deviation Rate, overdue Quality notifications etc. Prepare quality presentations based on these metrics for client meetings and hosts those meetings
• Identifies and recommends Quality improvements based on related trends from Quality systems. Leads Quality continuous improvement initiatives and provides quality assessments on process improvement (PPI) activities such as Mini Transformations or Kaizens
• Deputises for Snr QPL and Snr QA Operations Manager.
• Conducts internal audits and leads client, corporate audits and regulatory authority inspections as required. EH&S:
• Understand and ensure implementation of emergency procedures and 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.