Operations Associate
4 settimane fa
We’re looking for people who are determined to make life better for people around the world.
Responsibilities
Responsible for working with the Contract Manufacturer(s) (CM) to support supply, quality, and continuous process improvement of medicines supplied to Lilly sites and the market. The Operations Associate is accountable to the Joint Process Team Leader.
Key Objectives/Deliverables:
To support ongoing CM Operations by providing oversight at the Joint Process Team:
Facilitate the Joint Process Team between Lilly and the Contract Manufacturer. Monitor and communicate monthly JPT metrics. Support Huddles with a focus on KPIs with JPT Members. Foster and Support Strong Safety and Quality Cultures at the CMs. Support Launch/Divestiture Activities as needed. Provide day-to-day oversight of activities and resolve issues between the CMs and Lilly. Lead the resolution of manufacturing-related issues, including deviations/complaints and evaluation of manufacturing data and supply chain needs. Track timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation, product, process, and equipment reviews. Develop effective and productive working relationships with colleagues at CM and Lilly sites. Lead cross-functional/cross-site/cross-company project teams as needed. Regularly visit CM to increase awareness of operations and maintain strong working relationships. Manage conflict and problem resolution. Facilitate Lilly/CM Steering Team meeting agendas, with issues from the JPT requiring Steering Team actions. Present and document the decisions in Steering Team minutes. Support external and internal audits performed at the CM related to Lilly's product portfolio. Plan and execute product rationalization, termination, and market deletion when necessary. Provide backup, as appropriate, of the Joint Process Team Leader.Relationships:
Relationship with the CM:
Regularly visit CM to increase awareness of operations and maintain strong working relationships. Manage conflict and problem resolution. Support external and internal audits performed at the CM related to Lilly's product portfolio. Plan and execute product rationalization, termination, and market deletion when necessary.Others:
All key relevant functions at the contract manufacturers. All relevant functions at the Lilly IHL/Geneva office (if required). Drug product External manufacturing leadership. Lilly Manufacturing Procurement. Network within Lilly manufacturing sites to support the role and the relationship.Basic Qualifications
Master`s Degree or equivalent work experience in Pharmacy, Chemistry, Engineering, or similarly related fields Language spoken - fluent English.Additional Skills/ Preferences
Basic knowledge of parenteral processes Demonstrated experience aligning with delivering and assuring cGMP compliance of a production operation. Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools. Ability to representLilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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