Principal Quality Assurance Engineer
Posted 5 days ago by LanceSoft UK
Negotiable
Undetermined
Undetermined
Slough, England, United Kingdom
Summary: The Associate Principal QA Specialist (CQV) role in Slough, UK, is a 6-month contract focused on managing and supporting GMP issues through Quality Management System (QMS) processes and senior QA leadership. The position involves oversight of daily Quality Assurance activities in Validation and Technical Services, ensuring compliance with regulatory requirements. The specialist will mentor business partners in cGMP practices and contribute to continuous improvement initiatives. This role requires a strong understanding of quality processes and the ability to manage compliance issues effectively.
Key Responsibilities:
- Provide shoulder to shoulder review, approval and support for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations
- 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
- 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 project support to complex projects
- Perform other duties as assigned
Key Skills:
- 5-10 years of experience in Quality Assurance
- Advanced knowledge of GMP and quality processes
- Ability to manage compliance issues effectively
- Experience in mentoring and coaching
- Strong understanding of regulatory requirements (USFDA, European)
- Experience in continuous improvement initiatives
- Ability to maintain audit readiness
- Strong communication and collaboration skills
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.