Quality Assurance Specialist - In-Process Quality Assurance

Job Overview

The role involves meticulous monitoring and execution of quality assurance activities in pharmaceutical manufacturing, specifically within in-process quality assurance at the Goa facility.

Key Responsibilities

• Identify and communicate any quality issues or improvement suggestions to supervisors or management.
• Complete assigned training programs related to the QA In-process workgroup via the L2LMS (SABA) system.
• Perform in-process and finished product sampling and testing on bulk finished and packed samples.
• Carry out hold time studies and sampling at various stages including hold time, bulk finished, and packed samples.
• Conduct rounds for Quality Assurance to observe and document any deviations from SOPs and systems.
• Maintain and routinely calibrate instruments used in IPQC processes.
• Review logbooks and environmental monitoring documentation.
• Perform online audits of records regarding equipment use and cleaning, area usage, and balance calibration.
• Ensure line clearances for diverse production department activities.
• Execute, review, and approve critical documents like BRRs and ESPs within the PAS-X system.
• Oversee execution, review, and approval of batch manufacturing and batch packing records.
• Participate in equipment qualification activities as needed.
• Conduct cleaning validation and support equipment qualification efforts.

Required Experience and Education

Candidates should have between 1 and 5 years of relevant experience in the pharmaceutical quality assurance domain and hold a degree in Pharmacy or a related pharmaceutical field.