À propos du poste
Candidate will work with Quality Assurance Lead as a Compliance Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as an extension to the lead of compliance in regards to compliance oversight, which includes internal tracking systems and other areas that support manufacturing and regulatory agencies. Candidate will be working closely with other supporting members within the Quality Assurance Team supporting with track and trend of Change Controls, Deviations and CAPA closure. Candidate will need to understand sterile process, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
- Enter information in system to support compliance such as CAPAs, DEVs, CCR.
- Compile information for site lead using tracking systems in place.
- Follow GMP guidelines and adhere to SOPs and GMP requirements.
- Communicate QA with multiple departments and different levels of managements on status of compliance.
- Able to multi-task and manage projects within quality system.
- Support internal and external audits.
- Knowledge of pharmaceutical and or 503B environment and requirements.
- Experience working in a regulated environment (GMP)
- Ability to handle multi-task activities to support regulatory visits.
- Computer skills in excel, word, power point.
- Desire to work in an office setting as this position is not laboratory focused
- 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
- Associates degree in science, bachelor’s degree preferred
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.