Über die Tätigkeit
Summary: Candidate will work with Quality Assurance to ensure compliance of manufacturing processes in a GMP environment. This person will serve as on the floor presence to conduct inspections such as AQL and will also verify proper line clearances, visual inspection and documentation is completed accordingly. Candidate may also be involved in supporting with deviation/CAPA closure. The Senior MQA Assistant can expect every day to be different with changing responsibilities and priorities.
Responsibilities:
- Demonstrate and mentor MQ assistants during initial training, daily manufacturing processes and be a SME for all visual inspection processes within Quality.
- Provide daily leadership with MQ department to ensure that processes and departmental needs are addressed, prioritized appropriately without disruptions.
- Communicate departmental and production needs/issues directly with production and quality leadership as needed.
- Effectively manage time and assist with allocating resources to address quality responsibilities and needs.
- Be able to gown for ISO 8 qualified and ability to maintain qualification on a routine basis.
- Support manufacturing through an on the floor presence for line clearances, resolution of issues or elevation. Perform post production audits of the manufacturing process.
- Perform visual inspection AQL of product.
- Author and/or provide feedback addressing SOP updates for process changes
- Follow GMP guidelines and adhere to SOPs and GMP requirements
- Communicate QA issues to employees and managers in a tactful manner
- Work on multiple lots projects at once with changing deadlines and priorities
Ihr Profil
Experience/Profiles:
- Experience working in a regulated environment (GMP)
- Ability to handle multi-task activities to support production schedule.
- 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.
- Strong verbal and written communication skills specifically GDP.
- Minimal corrections for GDP throughout daily MQ paperwork activities.
- Work independently without direct supervision or guidance through daily activities.
Unser Angebot
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.