GENERAL DESCRIPTION

Lead Quality Risk Management exercises using several tools (i.e. FMEA, etc.) to define Environmental Monitoring sampling locations and contamination control strategy requirements, develop cleaning validation studies, protocols and reports, executable instructions in support of PR1 plant operations, all while working with a multidisciplinary implementation team

RESPONSIBILITIES
Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines Lilly del Caribe, this position has the following tasks and duties.
1.    Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
2.    Active participation on Contamination Control Strategy team meetings to provide input on activities, escalations and status of assigned tasks.
3.    Serve as Subject Matter Expert to lead Quality Risk Management exercises and author risk assessment reports. Responsible for implementation of identified actions. 
4.    Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and implementation of additional data integrity requirements. 
5.    Participate in the revision of the cleaning and contamination control strategy documentation records related to the manufacturing stages and steps.
6.    Lead and/or participate on triage activities to assess change control requirements. 
7.    Issuance or support on change control generation.
8.    Issuance change control and present it in Change Control Board to pursue approval of the change. 
9.    Review documentation associated to contamination control strategy and cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
10.    Revise SOPs related to cleaning program and contamination control strategy. 
11.    Lead trainings activities provided to manufacturing operators. 
12.    Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
13.    Comply with additional tasks requested by supervisor.
 

              The key experience and capabilities we need for this role are:

• Leading Quality Risk Management Exercises
• Knowledge of manufacturing Room Environmental Monitoring program and requirements
• Knowledge of Contamination Control Strategy programs
• Knowledge of cleaning validation program.
• Experience and training in FDA GMP.
• Good interpersonal skills with an assertive and pro-active approach towards work.
• Excellent communication skills (English and Spanish).

*Weil Group is proud to be an Equal Employment Opportunity Employer.*