Senior Quality Specialist

LGC Group; Greater London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global quality assurance company in Greater London is seeking a Quality Assurance Manager to maintain ISO certifications and implement a Quality Management System across corporate functions. Ideal candidates have a Bachelor's degree in a related discipline and a minimum of five years' experience in a regulated environment. The role includes leading and conducting internal audits and ensuring compliance with industry standards. This full-time position requires excellent interpersonal and organizational skills.

Qualifications

• Minimum of 5 years experience in Quality Assurance in medical devices, pharmaceuticals or biotechnology.
• Detailed knowledge of ISO 9001 and ISO 27001 standards.
• Auditor qualifications preferred, with attention to detail.

Responsibilities

• Maintain ISO9001 and ISO27001 certifications for the company.
• Implement Quality Management System across corporate functions.
• Ensure corporate QMS compliance with relevant ISO standards.

Skills

Strong interpersonal skills

Organizational skills

Verbal communication skills

Written communication skills

Attention to detail

Continuous improvement orientation

Team collaboration

Problem-solving skills

Education

Bachelor's degree in Science, Engineering or QA discipline

Tools

MS Word

MS Excel

MS Visio

MS PowerPoint

Job description

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, Communications, 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

• 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.

#ScienceForASaferWorld

Remote Work : No

Employment Type : Full-time

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