Qa & regulatory affairs officer - food and pharmaceuticals - united kingdom, abingdon, oxfordshire
position title:
qa & regulatory affairs officer - food and pharmaceuticals
position summary:
in this role you will be in charge for
systems: implementation, operation and improvement of the systems for the organization, with particular focus on food safety management and pharmaceutical gmp (but also cosmetics gmp to provide cover), ensuring these are compliant with the requirements, maintained and updated as part of the overall organization systems
people: work as part of the qa& regulatory affairs team and across the organisation with multi-department stakeholder teams
other: provide effective liaison between suppliers, customers and regulatory groups order to maintain a high level of customer satisfaction and compliance.
job description:
your responsibilities
design, implement, support and maintain management systems as required, with particular focus on quality, food safety, pharmaceutical gmp and cosmetics gmp management systems to ensure regulatory and legal compliance
ensure the good manufacturing practice (gmp) system in support of the pharmaceutical intermediate (and also cosmetics ingredient) product range
ensure the food safety management system meets iso / fssc 22000 and is effective in the support of our food product range
ensure we maintain our environmental compliance and environmental performance and certification of our iso 14001 system, in support of the qa&ra manager and ehs manager, who has prime responsibility
manage and co-ordinate a food safety team and organise its work
ensure relevant training and education of the food safety team members
maintain the kosher and halal quality assurance systems for our raw materials and finished products
report, via the qa & regulatory affairs manager, to top management on the effectiveness and suitability of the gmp, environmental, and food safety management system
liaise with external parties on matters relating to the gmp and food safety management system
review product batch manufacturing records, deviations and oos reports as part of the batch release process
maintain and train employees in the use of the quality and compliance software system used across the organisation for document management
lead the audit program, and conduct internal systems audits and supplier audits as required
host customer and regulator/certification audits in association with the qa & regulatory affairs manager and other department managers
investigate customer complaints in conjunction with the qa & regulatory affairs manager. ensure the relevant departments act promptly to investigate complaints and take corrective actions
investigate compliance issues in conjunction with the rest of the organisation.
prioritise and answer customer and regulator questionnaires, and manage relationships with such contacts
your profile
basic qualifications:
first degree in a physical, life or food science, preferably chemistry
at least 1 year working experience in a relevant area
an aptitude for food safety & quality systems management and document control
gmp knowledge and understanding of regulatory affairs
ability to understand new concepts and to assimilate and evaluate scientific data
analytical and problem-solving skills
structured working style with the ability to prioritize
affinity for documentation with a high attention to detail
highly motivated, willing to learn and take ownership
teamplayer, able to work in a cross-functional environment
huge customer orientation
excellent communication skills (written and oral)
preferred qualifications:
experience of qa & regulatory affairs and business systems within in a chemical manufacturing environment
working experience in food and/or pharma regulatory affairs
working knowledge of current regulated product manufacturing practices
management system auditing experience - internal and supplier auditing
additional details:
momentive believes a diverse workforce empowers our people, strengthens our business and contributes to a sustainable world. our leadership recognizes the many benefits that result from a more diverse workforce where individual and group differences are valued. we are firmly committed to improving our practices in meaningful ways to drive progress toward an equitable and inclusive environment for all, with an ultimate goal of a working environment where diversity, inclusion and belonging are deeply embedded in the fabric of our culture and felt by our people and communities.
we are an equal opportunity employer. all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran or any characteristic protected by law. to be considered for this position candidates are required to submit an application for employment and be of legal working age as defined by local law. additionally, where permitted by law, final candidates may be subject to a background investigation, medical fitness test and drug test depending on the role and the location of the position.
we cooperate with carefully selected external vendors supporting us on specific employment opportunities. momentive is not seeking or accepting any unsolicited assistance from search and selection firms or employment agencies at this time. please do not contact any of our employees by phone, email or otherwise about this position. please note that momentive will not be obligated to pay any cost or fee for candidate resumes that are submitted without the existence of a valid written and signed search firm agreement.
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