• Job Summary:
• Responsible for ensuring root cause analysis is conducted on investigations for OSD in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as quality technical resource and reviews all investigation reports for completeness and acccuracy, and compliance.
• Job Responsibilities:
• Conducts all OSD failures or deviations (product, validation, stability, process and procedures) and ensures investigations are initiated following existing procedure.
• Conducts investigations for product failures or deviations for both sites following existing procedures. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions. Writes product failure investigation reports for approval by Department Manager.
• Notify appropriate Team Leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and completed as per existing procedure. Act as quality technical resource and provide support & guidance to groups within Operations.
• Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager.
• Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, ect) and prepare recommendations for Department Managers.
• Prepare and maintain list of open investigation for OSD Management.
• Review on-going progress on all open investigations with Project Leaders and Coordinators.
• Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
• Project manages the corrective and preventative actions and assists in both implementation and follow-up.

• Bachelors degree in science
• 5-7 years experience in the pharmaceutical industry, preferably in Quality Engineering or QA/QC role.
• Experience in project management
• Fluency in project management & RCCA tools
• Superior organizational, interpersonal communication skills
• Ability to manage time effectively
• Ability to work independently and manage multiple priorities in a fast-paced and changing environment
• Good command of the English language, both written and verbal
• Knowledge of GMP
• Proficiency with Word, Excel, and SAP.

Please email your resume to Michael Aceto: michael@prideinpersonnel.com