lavori da Laboratory in località United States

Overview

• Monitor manufacturing compliance with GMP and statutory requirements.
• Ensure adherence to guidelines, procedures, and document controls.
• Achieve expected value stream targets as per business requirements.
• Maintain facility GMP compliance.
• Participate in team and process development.

Responsibilities

General Operating Activities

• Execute daily tasks and work instructions according to SOPs.
• Operate computer systems for data entry, report printing, etc.
• Perform data reconciliations and update databases.
• Edit and format SOPs as required.
• Generate reports as instructed.
• Verify data accuracy and audit documentation.
• Ensure documentation signatures are obtained and maintain proper filing.
• Perform additional work-related tasks as required.

Final Release of External Supply Products

• Review batch documentation for GMP compliance.
• Review product samples and artwork for SA Markets.
• Manage Post-Importation Testing (PIT) processes.
• Monitor blocked stock in warehouses.
• Conduct product release according to SOPs for SA and international markets.
• Manage product re-works per SOP and cGMP.
• Review data logger downloads for received products.

Investigating and Resolving QA Queries

• Coordinate feedback and reports from manufacturers and QA teams.
• Follow up on outstanding documentation and deviations.
• Approve and log deviations in consultation with QA management.
• Manage laboratory Out of Specifications (OOS) issues.
• Handle Suspect Stock Notifications and temperature excursions.
• Review raw material status and expiry data with CM.

Control of Highly Scheduled Substances

• Complete S6 requisitions and log samples.
• Maintain S6 register per MCC requirements.
• Apply for import permits for Schedule 5 and 6 medicines.
• Coordinate product launches requiring permits with MCC.
• Ensure permits are cleared and reconciled in time.

Management of QA Activities for New Product Launches and Re-alignments

• Request and review testing documents from Regulatory Authority.
• Coordinate Analytical Method Transfer (AMT) with PIT labs.
• Ensure timely ordering of reference standards and materials.
• Review batch documentation for new products or re-alignments.

QMS Metrics – SOPs, Deviations & Change Controls

• Initiate and review SOPs relevant to the role.
• Log and manage deviations and change controls.
• Conduct internal audits and compile reports.

Continuous Improvement Initiatives

• Identify process gaps and propose improvements.
• Manage assigned projects and provide progress feedback.

Human Resources and Compliance

• Adhere to company policies and labor legislation.

GMP Compliance

• Complete records and reports accurately and on time.
• Follow GMP/GLP requirements in all activities.

Health, Safety, and Environmental Standards

• Comply with OHS Act requirements and report unsafe conditions.
• Report incidents affecting health or safety.