Executive - QA (Pharma)

Keka Technologies Private Limited; Gujarat; On-site; INR 350,000 - 550,000; Full time

Job summary

Keka Technologies Private Limited is seeking a Jr. Executive / Executive to monitor production operations and ensure quality conformance during shifts. You will manage IPQA tasks, including SOPs, BMRs, BPRs and BCRs, and seal containers for finished products as required.

The role involves reviewing BMRs and analysis records before API release, preparing QC SOPs, STP and specifications, and performing API sampling with proper documentation control on site.

Responsibilities

• Take plant rounds to monitor production operations and verify quality conformance to specifications during shifts.
• Issue and control SOPs, BMRs, BPRs and BCRs, and seal finished product containers as part of IPQA activities.
• Review BMRs and analysis records prior to API release to ensure compliance.
• Prepare and review QC SOPs, STP and specifications to maintain quality standards.
• Perform sampling of APIs, maintain sampling records and ensure cleaning of sampling tools.
• Provide line clearance at product changeovers to ensure proper transitions.
• Conduct documentation control activities at the site.
• Monitor, maintain, and review records and handling of controlled/retained samples of intermediates/finished API.

Job description

Jr. Executive / Executive - Job Description:

• To take plant round for monitoring of entire production operations and confirm quality conformance to specifications in shift.
• To Issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities.
• To review BMRs, BCRs and analysis records before release of API.
• Preparation & review of QC SOPs / STP / Specifications.
• To perform sampling of APIs, maintain its records and ensure the cleaning of sampling tools.
• To provide line clearance at the time of product changes over.
• To perform the documentation control activity at site.
• To monitor/Maintain/Review of Records and Handling of controlled/Retained samples of Intermediates/Finished API.