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
Positive 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.
Solid understanding of GMP and GDP is required.
Experience in the preparation and/or review of SOPs and BMRs is mandatory.
CSV knowledge is necessary

📌 Sr Executive/am In Process Quality Assurance Ipqa Umarsadi
🏢 Adler Talent Solutions
📍 Umarsadi