Quality Assurance Engineer Home based - 50% travel
Ideally based near good travel links, perhaps Midlands. Offices Lincolnshire & Northern Ireland
Responsible for creating and improving the quality system for cosmetic products.
• Develop SOPS to define key quality processes
• Develop batch record template and assist in the development of product specific batch records
• Manage the CMO (Contracting Management Organisation) quality process
• Investigate quality problems and facilitate the development and completion of corrective actions
• Audit key suppliers and service providers to ensure compliance to applicable quality and regulatory standards
• Create system for quality records
• Monitor product quality performance to identify trends
• Participate in the product realization process to ensure quality and regulatory considerations are addressed
• Bachelor’s Degree preferably in scientific or engineering discipline.
• A minimum of five years’ experience in quality assurance
• Progressive experience in a similar role within a cGMP environment in pharmaceutical, cosmetics, or the food industry with working knowledge of 21 CFR 210 and 211 , ISO 22716, or ISO 22000.
• Experience developing product label copy a plus.
• Ability to problem solve and to be able to fully participate in diverse cross functional teams to achieve the business objectives.
• Excellent written and verbal communications skills. A service-centred, team-building, can-do attitude would be appreciated.
• Ability to handle multiple tasks simultaneously, having good planning and organizational skills.
• Strong proficiency in Microsoft Office suite of products and experience with application software and equipment control systems hardware/software/firmware with the ability to navigate and document varied human-machine interfaces.
The successful candidate:
• Can assess and prioritize tasks based on overall job goals
• Will work in an unstructured environment and meet key deadlines
• Will work with others to create solutions
• Can use systematic approach to identify root cause
• Can use data effectively to support the decision-making process
• Will research, understand, and apply relevant regulatory requirements for the cosmetic product line
• While performing the duties of this job, the employee is occasionally exposed to outside weather conditions while going in and out of office buildings.
• The noise level in the work environment is usually moderate.
• Successful candidate may work from a home office. Travel up to 50% primarily within the U.K.
Reporting To: Vice President of Quality Assurance direct, Operations Manager indirect