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

Adler Talent Solutions; Valsad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Adler Talent Solutions in India seeks an experienced QA professional to oversee documentation control, in-process quality activities, batch record reviews, change control, validation, and calibration to ensure product quality, regulatory compliance, and continuous improvement across manufacturing operations.

The role requires hands-on CAPA, deviation management, line clearance, and a strong GMP/GDP background, with experience in SOP/BMR preparation and CSV knowledge.

Qualifications

• 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.

Responsibilities

• 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 with 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.

Skills

Communication skills

CAPA

Change Control

Deviation Management

Line Clearance

GMP

GDP

SOPs/BMRs

In-Process QC

CSV knowledge

Job description

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