IPQA Associate I

The IPQA Associate I is responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Job Description :

• Focuses on initial deviation investigative phases related to manufacturing process deviation.
• Responds to customer calls for assistance, documentation and immediate corrective action associated with deviations.
• Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions.
• Performs area assessments and ensures compliance with SOPs, Policies and Procedures.
• Leverage on-the-floor presence to proactively identify opportunities and provide coaching.
• Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
• Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
• Administration and management of deviations / investigation / Client systems in Trackwise.
• Control materials for compliance purposes in SAP.
• Execute the final release inspection of packaging lines.
• Perform acceptance sample analysis for validation and investigation support.
• Responsible for the review and approval of controlled documents including manufacturing and packaging batch records.
• Actively communicate with customers to facilitate continuous process improvement.
• May complete specific project work such as process improvement / remediation, maintain ownership and responsibility for specific QA processes.

Education and Experience

• Minimum of Bachelor s degree.
• Understanding of GMPs.
• Expertise in software applications such as : MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools.
• Strong interpersonal and communication, both written and verbal, skills.
• Strong organizational and time management skills;must be a ble to prioritize and manage multiple assignments simultaneously.
• A self-starter with a hands-on approach and a can-do attitude.
• Minimum two (2) years of experience within the pharmaceutical industry in quality function role.
• Experience working in an international multicultural matrix organization.

Last updated : 2024-05-13