Quality Specialist - 226139
Spreadsheet Verification:
Set a schedule for regular verification, perhaps weekly or monthly, depending on the volume of dataUse 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.
Recommended Skills Attention To Detail Auditing Decision Making Regulatory Requirements Spreadsheets Stress Management Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
Set a schedule for regular verification, perhaps weekly or monthly, depending on the volume of dataUse 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.
Recommended Skills Attention To Detail Auditing Decision Making Regulatory Requirements Spreadsheets Stress Management Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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