O pracovní pozici
Summary:
Work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. Serve as on the floor presence for line clearances, visual inspection performance, investigation support, deviation/CAPA closure. Every day may be different with changing responsibilities and priorities.
Responsibilities
- Be able to enter CNC areas to perform all MQ functions as needed.
- Support manufacturing through an on the floor presence for line clearances, resolution of issues or elevation.
- Perform AQL of visual inspection and labelling operations.
- Assist in facility and/or supplier assessments and raw material/component release.
- Assist in authoring and updating applicable SOPs as needed.
- Follow GMP guidelines and adhere to SOPs and GMP requirements.
- Communicate QA issues to employees and managers in a tactful manner.
- Assist with multiple project tasks at once with changing deadlines and priorities.
- Communicate shift and business needs with leads, pharmacists and colleagues to ensure priorities are met.
Vystupte z davu
Requirements:
- 2+ years Pharma experience with Quality experience preferred.
- HS Diploma, Bachelor’s degree preferred.
- Experience working in a laboratory or process manufacturing setting
- Experience working in a regulated environment (GMP)
- Ability to be clean room qualified and maintain qualification routinely
- Have 20/20 vision, correctable with glasses/contacts
- Be able to be visual inspection qualified and maintain qualification
- Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure
- Strong verbal and written communication skills
- Technical writing and review ability
- Desire to work in an office setting as this position is not laboratory focused
Co nabízíme
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.