Role: Associate Principal QA Specialist (CQV)
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 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.