Back to jobsPerform line clearance and release activities according to established Standard Operating Procedures (SOPs).
Conduct in-process quality checks on products during manufacturing and packaging, ensuring results are within defined limits and timelines.
Accurately document all test results and observations in batch-related documentation to ensure complete traceability and compliance.
Ensure the correct materials and components are used in production and packaging, following specifications outlined in BMR (Batch Manufacturing record), BPR (Batch packaging record), MPI (Master Packaging Instructions), MIV (Material Issue Voucher), or Dispensing Sheets.
Maintain strict adherence to current Good Manufacturing Practices (cGMP) within the assigned area, ensuring proper documentation, verification of entries, and record integrity across batch records, logbooks, and labelling systems.
Verify proper gowning attire, cleanliness, and adherence to SOPS, manufacturing instructions, and packaging instructions.
Ensure environmental conditions (temperature, humidity, and differential pressure) meet the requirements for the product and the work area.
Verify that in-process check equipment is properly calibrated and functions as intended.
Assist in preparing the Annual Product Quality Review (APQR) for products as per established