Principal Quality Assurance Engineer

Role: Associate Principal QA Specialist (CQV)

Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.

Location – Slough, UK

6 months contract

Role Purpose & Scope

Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA Leadership. Provide oversight on day-to-day Quality Assurance activities in the areas of Validation / Technical Services in accordance with Lonza Corporate requirements, standards and current regulatory requirements, meeting USFDA, European requirements and others as applicable for a multi-product, GMP biotech contract manufacturing facility.

Required Skills & Competencies

Work Experience Area -QA

Level- Advanced - 5-10 years

Key Responsibilities

To provide shoulder to shoulder review, approval and support for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations

To provide oversight over day-to-day Quality assurance activities in the areas of Technical Services and Validation in accordance with the client Corporate requirements, standards and current regulatory requirements

Utilize knowledge of GMP and quality processes within the functional areas to: Manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs

To actively identify, suggest and participate in continuous improvement activities

Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment

Maintain and promote a state of audit readiness

Actively suggest, initiate, participate xwzovoh and contribute to PQS process improvements initiatives and projects

Provide QA SME support at departmental Local Quality Councils and project meetings

Provide shoulder to shoulder review, approval and QA Technical support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations

Provide coaching and training to other team members

Provide QA SME support at departmental Local Quality Councils and project meetings

Provide QA project support to complex projects

Performs other duties as assigned.