Job description

Perform sampling and testing during the production process.
Collect samples of finished products, both bulk and packed.
Carry out hold time studies including sampling at hold time stages for bulk finished and packed products.
Conduct Quality Assurance rounds to identify deviations from procedures and systems; document observations thoroughly.
Maintain in-process quality control (IPQC) instruments and ensure routine calibration is performed timely.
Review logbooks and records related to environmental monitoring.
Monitor records concerning equipment usage, cleaning, area utilization, and balance calibration online.
Authorize line clearances for various production activities.
Responsible for execution, review, and approval of Batch Record Reviews (BRRs) and Equipment Standard Procedures (ESPs) using PAS-X system.
Handle execution, review, and approval of batch manufacturing and packing records.
Participate in equipment qualification processes as required.
Manage cleaning validation and equipment qualification executions.
Fulfill customer requirements including sample provision and document management.
Review, prepare, and revise documents as necessary to meet quality standards.
Engage in shop floor investigations related to in-process out of specification (IPOOS), deviations, line clearance failures, material discrepancies, and similar issues.

Between 3 to 5 years of relevant experience.

Professional competencies consistent with quality assurance in pharmaceutical manufacturing.

Executive