Over de functie
The post production E2 Lead will support post production management by acting as one of the primary persons responsible for the logistics associated with scheduling for visual inspection and labelling activities at Fagron Sterile Services-E2. Additionally, the Lead will serve as liaison to other functional areas within the FSS organization.
Responsibilities:
· Planning and Managing- Developing a daily plan, delegating tasks to team, and ensuring that daily tasks are completed timely and accurately.
· Communicating- Relaying important information to shift associates and when necessary to post production management.
· Motivating- Creating a positive work environment and helping team members achieve organizational goals. Responsibilities of the Post Production Lead-E2:
· Ensure operations are performed in a safe & compliant manner that supports the post-production quality and operations performance goals and objectives.
· On the floor leader that will plan, orchestrate, train and even perform daily activities associated with post-production; specifically, visual inspection and labeling being performed in the E2 areas.
· Ensure training and compliance of all activities performed in the E2 areas.
· Collaborate with investigators regarding CAPAs, deviations, test kit maintenance and root cause analysis interviews.
· Support post-production team to execute visual inspection, tamper sealing, labelling and bagging activities. This includes but is not limited to scheduling of batches execution of above-mentioned activities,
· Ensuring proper completion of documentation required for each action associated with the batch
· Ensure that all rejected materials are documented and destroyed appropriately.
· Assist team with routine inventory counts and reconciliation as often as and outlined in standard operating procedures.
· Continuous monitoring of material accountability records for errors, completions of review and verification signatures.
· Clerical tasks including data entry, scanning, organizing, and storing of controlled documents.
· Support operations by acting as SME during audits and site procedure compliance for all daily activities.
Maak het verschil
Profile/Experiences Qualifications:
· High School Diploma or equivalent required.
· Excellent time-management skills and ability to self-direct in managing concurrent requirements.
· Ability to communicate with colleagues, customers, suppliers, in person, on the phone, and by written communications in a clear, straightforward, and professional manner to clearly convey priorities and need.
· Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
· Proactive, problem-solving mindset – ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.
· Must be able to meet all requirements for handling of controlled substances.
· Working knowledge of GDP principles as relating to a pharmaceutical manufacturing environment. Previous work experience in a regulated manufacturing industry a plus.
· Familiarity with and/or willingness to learn ERP system tracking and management.
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.