Senior Quality Assurance Executive

Cadchem; Dera Bassi; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Cadchem in Punjab, India is seeking an experienced QA professional to oversee GMP quality systems. You will coordinate Change Control, SOP management, and CAPA to ensure product quality and regulatory compliance.

The role requires hands-on review of deviations, equipment qualification activities (DQ/IQ/OQ/PQ), process validation, cleaning validation, and batch records closure, with cross-functional support. Strong documentation skills and a proactive problem-solving mindset are essential.

Qualifications

• Experience in GMP QA with Change Control and deviation investigations.
• Knowledge of SOP drafting, review, and training.
• Familiarity with equipment qualification (DQ/IQ/OQ/PQ).
• Ability to perform RCA using 5-Why and Fishbone tools.

Responsibilities

• Coordinate Change Control activities including impact assessment and closure.
• Prepare, review, and control SOPs and GMP documents.
• Manage SOP revisions with timely review and training.
• Support Equipment Qualification activities (DQ/IQ/OQ/PQ).
• Handle Deviation investigations, assessments, documentation, and closure.
• Coordinate and review Process Validation protocols and reports.
• Handle Cleaning Validation protocols, sampling plans, and results.
• Coordinate CAPA identification, implementation, and closure.
• Perform Root Cause Analysis using 5-Why and Fishbone.
• Review Batch Production/Manufacturing Records for compliance.

Skills

Quality Assurance

GMP compliance

Change Control

Deviation investigations

CAPA

Process Validation

Documentation control

Root Cause Analysis

Job description

Key Responsibilities

• Handle and coordinate Change Control activities, including impact assessment, implementation, and closure.
• Prepare, review, and control SOPs, specifications, formats, and other GMP documents.
• Manage SOP revisions and ensure timely review, approval, implementation, and training.
• Support and review Equipment Qualification activities such as DQ, IQ, OQ, and PQ.
• Handle Deviation investigations, assessment, documentation, and closure.
• Coordinate and review Process Validation protocols and reports, including validation planning, execution, data review, deviation assessment, and final report approval.
• Handle Cleaning Validation activities, including preparation/review of protocols and reports, sampling plans, acceptance criteria, swab/rinse sampling, recovery studies, and evaluation of analytical results.
• Coordinate CAPA identification, implementation, effectiveness checks, and closure.
• Perform/support Root Cause Analysis (RCA) using appropriate investigation tools such as 5-Why and Fishbone Analysis.
• Review BPR/BMR (Batch Production/Manufacturing Records) for completeness, compliance, and adherence to approved procedures.
• Ensure proper review of manufacturing and packing documentation before batch release/approval as applicable.
• Monitor compliance with GMP, SOPs, data integrity, and quality systems.
• Coordinate with Production, QC, Engineering, Warehouse, and other departments for investigation and quality-related activities.
• Support investigation of process/product-related quality issues and implementation of corrective and preventive actions.
Maintain QA documentation and ensure timely closure of assigned quality-system activities.
• Provide QA support for API manufacturing processes and demonstrate good understanding of manufacturing operations and process controls.