Quality Systems Specialist
Cambridge, MA | Contract
Softworld Inc is actively seeking a Quality Systems Specialist to participate in a team to perform all data entry of a total of 251 CMC Change Control records from the Legacy EMS system into a recently harmonized Global Electronic Quality Management System. If this sounds like a role for you, let’ s talk!
• The Global EQMS interfaces with an application called PRISM (client's Product Registration Information and Submission Management system). A component of this data entry project will include mapping the current regulatory impact assessments from EMS to Events in PRISM, and ensuring that impacted markets and regulatory assessments are appropriately displayed in Global EQMS, after data entry into PRISM has been completed by client's Central Data Entry Team (CDET).
• This individual works cross-functionally in a virtual setting, interacting routinely with members from O&B Quality Systems and client Global Regulatory Affairs to meet assigned data entry tasks per project timelines accurately and completely.
• Completes data entry of legacy changes into Global EQMS and completes PRISM Data Entry form based on assigned weekly schedule, such that activities are conducted in a timely and efficient manner, project milestones are met, and GXP compliance is maintained.
• Enters open legacy Commercial CMC Change Control records from EMS into Global EQMS for the seven (7) Commercial products for which TBOS either has quality responsibility for, or is the Market Authorization Holder.
• Determines the impacted markets and associated regulatory impact assessments for each open legacy change and completes the PRISM Data Entry form with this information.
• Ensures that the PRISM Data Entry form is reviewed by the applicable Global Regulatory Affairs representative for accuracy and completeness, prior to sending the form to the PRISM Support Central Data Entry team (CDET) for entry into PRISM.
• Reviews communication back from PRISM team to verify that all markets have been entered and are reflected in Global EQMS, that filing types entered are accurate, and that the correct dispatch, submission and approval dates are reflected for each market.
• Collaborates with PRISM Central Data Entry Team when applicable to ensure any corrections are made.
• Verifies with Quality Systems contact that change is completely and accurately entered into Global EQMS.
• Meets with individual employees and/or groups, both on site and or remotely on a regular basis to discuss data entry status, to prioritize, and assign work and projects.
• Develops and maintains strong internal relationships with project team and cross-functionally, as needed.