Kaztronix
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IPQA Associate I
Job Description
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:
Education and Experience
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 able 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.
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