Senior Quality Specialist

LGC Group Ltd; City of Westminster; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global life sciences company is seeking a Quality Assurance professional to maintain compliance with ISO9001 and ISO27001 standards. This full-time role involves implementing and managing a Quality Management System, conducting internal audits, and fostering a collaborative work environment. The ideal candidate will have at least a Bachelor's degree in a relevant field and a minimum of 5 years' experience in Quality Assurance within a regulated industry. Strong communication skills and attention to detail are essential.

Qualifications

• Strong interpersonal, organizational, verbal and written communication skills.
• Minimum of 5 years industry experience in a Quality Assurance role in a regulated environment.
• Detailed working knowledge of ISO 9001 and ISO 27001.

Responsibilities

• Maintenance of ISO9001 and ISO27001 certification.
• Implement a Quality Management System for corporate compliance.
• Conduct internal audits and maintain QMS records.

Skills

Quality Assurance

FDA Regulations

Data Collection

Food Safety Experience

ISO 9001

Mobile Devices

Root cause Analysis

Quality Systems

OSHA

Food Processing

Quality Management

cGMP

Education

Bachelor's degree in a relevant Science, Engineering or QA discipline

Tools

MS Word

Excel

Visio

PowerPoint

Job description

Key Responsibilities

• Maintenance of both ISO9001 and ISO27001 certification and accreditation for LGC Group.
• Responsible for Implementation and Maintenance of a Quality Management System across Corporate functions to ensure compliance to applicable standards and industry Best Practice where necessary.
• Ensure that the Corporate QMS is compliant to the relevant ISO standards and remains audit ready at all times. Inclusion of Finance Comms HR IT Procurement and Legal within the scope of the QMS.
• Provide direction and guidance to the Corporate team in execution of and compliance with the Quality Management System.
• Provide and document Quality Management System Framework including training of new employees. Accurate review and approval of records SOPs and established standards for QMS compliance.
• Ensure accurate QMS records related to nonconformances deviations and CAPAs as applicable. Work with functional groups to investigate quality issues determine root cause and suggest and implement corrective and preventive actions.
• Review and approval of protocols reports and change management documentation ensuring defendable practices and conclusions.
• Utilise quality tools to track and trend quality performance and identify key opportunities for improvement.
• Process and approve document change requests. Perform internal audits issue audit reports and follow up to close out actions which address the findings.
• Implementation and execution of a Management Review process in compliance with applicable ISO standards.
• Integration of Corporate QMS processes with ISO 27001 requirements.
• Promote and contribute to continuous improvement activities.
• Coordinate and host audits and regulatory inspections.
• Provide advice to other departments to ensure compliance with company policies procedures and best practices.
• Provide training on new and existing SOPs and major updates to SOPs and maintain training records.
• Maintain LGC Group Quality Manual and Policy.

Core Values

• Passion
• Curiosity
• Integrity
• Brilliance
• Respect

We deliver world-class solutions and foster an inclusive and collaborative environment where every team member can thrive and achieve their full potential!

Equal Opportunity Statement

We are committed to ensuring that every job applicant and employee is valued for their individual talents. We strictly prohibit discrimination on the basis of age disability race colour ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership pregnancy or parental status religion or belief. We proudly support an inclusive work environment where everyone can compete and succeed based on their merits.

#ScienceForASaferWorld

Employment Details

Remote Work : No Employment Type : Full-time

Qualifications

• Strong interpersonal organizational verbal and written communication skills.
• Demonstrates curiosity integrity brilliance respect and passion; works best in a team environment and actively seeks to foster relationships.
• Self-starter able to develop relationships across global business unit teams.
• Ability to ask probing questions to understand unstated expectations and underlying issues understand competing priorities and facilitate discussions to gain consensus.
• Oriented to continuous improvement.
• Impeccable attention to detail.
• Minimum of a Bachelors degree in a relevant Science Engineering or QA discipline.
• 5 years industry experience working in a Quality Assurance role in a regulated environment for medical devices pharmaceutical or biotechnology industry.
• Auditor (preferably lead auditor) QA qualifications.
• Detailed working knowledge of ISO 9001 or equivalent Quality Management System principles.
• Detailed working knowledge of ISO 27001 and international regulatory requirements.
• Proficiency in MS Word Excel Visio and PowerPoint required. Working knowledge of statistical analyses required.

Key Skills

• Quality Assurance
• FDA Regulations
• Data Collection
• Food Safety Experience
• ISO 9001
• Mobile Devices
• Root cause Analysis
• Quality Systems
• OSHA
• Food Processing
• Quality Management
• cGMP

Experience : years Vacancy : 1