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Description: Support labeling changes, shelf-life extensions for contract manufacturing sites and internal sites. Work with internal and external stakeholders for to develop change management and implementation plan. Review and approve labeling component artwork. Collaborate with Supply Chain and assess the product forecast. Develop the implementation plan for labeling changes and document the labeling change details in change control system, Participate in weekly tele-conference with CMO sites. Manage the implementation timing of labeling components at CMOs. Review CMO change controls, BOM, specifications and other documents. Manage and lead labeling change projects at multiple CMO sites. Ensure labeling changes are implemented at CMOs in a timely manner. Support the engineers with package testing as required.Day to day for the person: Currently the team is going through document migration- the person will be transferring the documents and routing the documents
Labeling changes of packaging inserts etc and ensuring things are within compliance. Creating change management records and routing documents
80% of job- attending meetings and collaborating with various groups
Package testing- more infrequent tasks
Skills:quality assurance, labeling software, project coordinationAdditional Skills & Qualifications BS degree is required. Drug product and pharm background (including nutraceuticals) is acceptable; packaging would be great, but not required. Trackwise and Veeva are nice to have - must have experience with quality systems
Excellent interpersonal skills and ability to work effectively with people.
Strong verbal and written communication skills. Prior job or internship experience from pharmaceutical or medical device company is desired. Good organization and project management skills required to simultaneously manage multiple labeling change projects with different CMO sites. Experience with MS Office Suite and technical writing skills. Experience with pharmaceutical packaging, labeling and artwork review is a plus. Experience with labeling change management is a plus. Experience with GMP systems is a plus.Experience Level:Intermediate LevelAbout Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Vacancy expired!