Job Title: Principal QA Specialist - Global Biopharmaceutical Contract: 12 monthsLocation: Slough (onsite)Salary: £31.99 PAYE, £40.47 Umbrella per hour (Inside IR35)Hours: 37.5 hours per weekThe Principal QA Specialist will act as a Subject Matter Expert for Quality at the site level with the primary focus on SQC preparation and publishment, Deviation process including Track & Trend, quarterly reports, monthly emails, QRM process and PQS statistic toolsJob Responsibilities:SQC preparation and publishment - being accountable for the preparation and coordination of the monthly SQC slides and summaries and the required data.
After the meeting, finalisation of the meeting minutes and publication in the local DMS system.Deviation process including Track & Trend, quarterly reports, monthly emails - represent Lonza Slough site during the global meetings, coordinating the communication and any questions raised.
Be the main point of contact for any questions raised, audit observations , CAPAs associated with this topic.
Be responsible for providing strategic expertise in this topic.
Be responsible for resolving escalated PQS internal issues.Calculate / review deviations Event Category limitsQRM process - being accountable for ensuring the process is aligned with the Lonza Global standards.
Act as a SME for QRM related questions, audit observations, CAPAs and others.
Be responsible for providing strategic expertise in this topic.
Be responsible for resolving escalated PQS internal issues.PQS statistic tools used for preparation and extraction of the data, statistical analysis to support the compliance of the business.Provides continued inspection readiness at site including ongoing remediations and in line with Lonza and regulatory standards.
Utilise knowledge of GMP and quality processes to actively identify, suggest, participate in and manage continuous improvement to ensure that PQS remains effective , efficient, simple and compliant.Essential Requirements:BSc in Science or QA discipline.Has the personal determination to make performance happen with people not in reporting lines.Excellent decision making skills.Ability to meet strict deadlines.Excellent organisational and planning skills.Ability to streamline/ lean processes.
Be open-minded with the enthusiasm and motivation to learn, improve and innovate.Demonstrates an ability to see the big picture.Excellent communication skills (verbal and written).Believes diversity creates strength within the team.Embraces and creates collaborative relationships.Has the clarity of thought to deliver clear unambiguous communication.