Quality Specialist

Spreadsheet Verification: Set a schedule for regular verification, perhaps weekly or monthly, depending on the volume of data. Use automated validation tools where possible to streamline the process.

Data Binder Review/Release: Establish a clear process for reviewing and releasing data binders, ensuring that all necessary documentation is complete and accurate before approval.

Review/Approval of Study Protocols: Prioritize reviews based on project timelines and ensure thorough understanding of protocols to provide timely feedback.

Review/Approval of Interim & Final Reports: Allocate time for thorough review of reports, balancing attention to detail with meeting deadlines.

Review/Approval of Test Methods: Stay updated on industry standards and regulatory requirements to efficiently review and approve test methods.

Review/Approval of Certificates of Analysis (CoA): Implement a streamlined process for reviewing and approving CoAs, verifying accuracy and compliance with specifications.

Review/Approval of OOS/OOT (Out of Specification/Out of Trend): Act promptly to investigate and resolve OOS/OOT results, ensuring compliance with regulatory requirements.

Review/Approval of Deviations: Establish a protocol for documenting and reviewing deviations, ensuring thorough investigation and appropriate corrective actions.

Review/Approval of CAPA (Corrective and Preventive Actions): Prioritize CAPA actions based on risk and impact, ensuring timely implementation and effectiveness.

Author New or Revised SOPs: Dedicate time for drafting and reviewing SOPs, involving relevant stakeholders for input and approval.

Monthly Audit of Instrument Logbooks: Schedule regular audits and allocate time each month to review instrument logbooks for completeness and compliance.

Participate in Sponsor Kick-off Meetings, Teleconferences, and Visits: Prioritize participation in these meetings, preparing in advance to contribute effectively to discussions and decision-making.

Participate in Regulatory Audits: Prepare thoroughly for regulatory audits, ensuring all documentation is in order and actively participating in audit activities.

Assist Quality Manager in Responding to Audit Reports: Collaborate with the Quality Manager to address audit findings promptly and comprehensively, implementing necessary corrective actions.

Conduct Internal Audits: Follow the internal audit schedule, conducting audits with attention to detail and impartiality, and documenting findings appropriately.

Follow cGMP Guidelines and Regulatory Requirements: Stay updated on cGMP guidelines and regulatory changes, ensuring all activities comply with applicable regulations.