GMP Clinical Packaging Lead (ONSITE- 2nd SHIFT)

29 Mar 2024

Vacancy expired!

Please note that this is a 1 year contract position with benefits.This is a second shift position. Clinical, Medical Device/ Pharmaceutical industry background is required.MUST HAVES: GMP experience, previous experience following SOPs and proper documentation practicesNICE TO HAVE: Close attention to details, Timeliness (complete projects by deadline), Able to work independently or with a small team.Requirements:GMP Experience Experience following SOPs and proper documentation practicesProficient in Microsoft Office Applications such as Word and Excel Experience working cross-functionally Able to work independently and meet project deadlines Strong attention to detailDescription: Responsible for overseeing clinical packaging operations as well as completing compliance and quality-related tasks within the Global Clinical Supplies Packaging group, including personnel scheduling and training, ensuring preparation of investigational drug products meets current quality standards, investigating clinical complaints and deviations, developing corrective/preventative actions, and updating Standard Operating Procedures.Responsibilities:Ensure personnel are adequately trainedManage/Schedule personnel for GMP activities Oversee and manage the GMP compliance of staffAuthor SOPs within the functional area Manage the ordering and inventory levels for secondary packaging components Provides Quality oversight to the packaging area through the following: Perform complaint and deviation investigations with a focus on true root cause, and creation of appropriate CAPA's. Drive CAPA's to closureEnsure clinical supplies are processed according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies Participate as subject matter experts during internal or external audit from Quality group, safety bodies or regulatory agenciesGenerate and oversee the change controls necessary for the movement or modification to existing packaging equipment Support creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles as they relate to clinical supplies and participates in adjustment of logistics pertaining to drug supply. May involve liaison with Global Clinical Supplies or external partner groupsContribute to the Global Clinical Supplies packaging, labeling, or distribution strategy through participation in process, providing expert technical review and approval of proposals May represent Global Clinical Supplies on cross-functional teams or represent Operations group on internal teams as appropriate. Will undertake specific projects within the group on as needed basisApplicants must provide their phone number. Reference job number A3255.

  • ID: #49582073
  • State: Pennsylvania Westpoint 19486 Westpoint USA
  • City: Westpoint
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2023-03-29
  • Deadline: 2023-05-27
  • Category: Et cetera