Over de functie
Job Summary:
The Quality Assurance Assistant will ensure compliance of manufacturing processes in a GMP environment and will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project orientated, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.
Role Responsibilities:
- Support the Quality Department with the review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance
- Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products
- Support Customer Complaint department in the intake, investigation, reporting and closure of complaints in a timely manner.
- Author and update SOPs as needed
- Follow GMP guidelines and adhere to SOPs and GMP requirements
- Communicate QA issues to employees and managers in a tactful manner
- Work on multiple projects at once with changing deadlines and priorities
Maak het verschil
Requirements:
- High School or equivalent is required. Associate’s or bachelor’s degree in a science filed is preferred
- Experience working in a manufacturing or laboratory setting
- Experience working in a regulated environment (GMP)
- Detail oriented
- Ability to work independently and interdepartmentally
- Strong verbal and written communication skills
- Technical writing and review ability
- Experience with MasterControl or similar Quality Management System would be preferred
Wat bieden wij?
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.