Company Description
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomics and for quality assurance applications. LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products.
Job Description
- 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.
- Work with quality teams/representatives across Business Units to support alignment, coordination and best practice sharing across the LGC group
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 Bachelor’s 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.
Additional Information
Our Values
BRCGS operates with five core values that underpin everything we do:
- 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 opportunities
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.
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