Sr. Executive/AM- In Process Quality Assurance (IPQA)

Role & responsibilities

Role: The position involves overseeing documentation control, In-Process Quality Activities, Batch Record reviews, Change Control, Validation, and Calibration activities to ensure product quality, regulatory compliance, and continuous improvement across manufacturing operations.

Main Tasks :

• Ensure effective control of documents, including preparation, review, issuance, archival, retrieval, and destruction as per defined procedures. 
• Support implementation and maintenance of the Quality Management System (QMS) in line which applicable quality standards. 
• Perform line clearance and ensure compliance during operational and processing activities. 
• Carry out in-process quality activities such as sampling coordination, documentation review, data evaluation, and compliance checks. 
• Prepare and review reports related to environmental monitoring or process controls, as applicable. 
• Review material transfer and receipt records from warehouse to operations to ensure adherence to procedures. 
• Review and verify batch, process, or operational records for accuracy, completeness, and compliance. 
• Review drawings, specifications, or technical documents from a quality perspective. 
• Support preparation and review of periodic quality reports and summaries. 
• Handle change control activities, including documentation, review and coordination for implementation. 
• Perform sampling, execution, and documentation related to qualification or validation batches. 
• Monitor calibration and validation activities to ensure timely execution and compliance. 
• Prepare and review conformity or compliance certificates as required. 
• Assist in execution, coordination, and documentation of calibration and validation activities.

Preferred candidate profile

• Good communication skills are essential.
• 2 - 15 years of Experience in Pharmaceutical Industry is preferred (Injectables experience is must).
• Hands-on experience in CAPA, Change Control, Deviation Management, and Line Clearance is mandatory.
• Strong understanding of GMP and GDP is required.
• Experience in the preparation and/or review of SOPs and BMRs is mandatory.
• CSV knowledge is necessary