Works independently on projects and problems of complex scope and may coordinate the activities of others as needed. This individual should have "hands on" skills and may perform some development/scripting activities as new connectors are established across additional corporate applications.
Provide troubleshooting assistance and suggest remedial and corrective actions in the case of unacceptable validation results. Sme/lead investigations by assembling and coordinating cross-functional teams to determine root cause and corrective actions for unacceptable validation results.
Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (qa, ra, validation, production, ect) and prepare recommendations for department managers.
Contributes to decision making on study design, data collection, and analysis by independently recommending appropriate statistical methodology, ensuring alignment with study objectives and regulatory guidelines.
Responsible for taking lead in the investigation, diagnosis and resolution to master data, process and technology incidents impacting gapi. Act as management representative in decisions leading to stabilizing systems used in daily operations;
Use automation systems expertise to work with individual stakeholders, to ensure the appropriate change controls, commissioning, qualification and training plans with accompanying resources are in place to deliver efficient system start-up.
Responsible for overseeing daily activities of the Production group and ensure that all production operations personnel work in compliance with cGMP guidelines, departmental and company policies and Government regulations.