Quality Assurance/ QA / QC Executive

Role Overview

We are looking for a strong and experienced professional for Quality Assurance and Regulatory Affairs in the chemical & Textile manufacturing industry. The candidate should be capable of independently handling QA systems, regulatory compliance, audits, documentation control, and coordination with international regulatory bodies and foreign delegates.

Key Responsibilities

Quality Assurance & Compliance

 Review and approval of Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, protocols, reports, formats, and controlled documents.

 Handling and monitoring of IPQA activities across manufacturing and packing departments.

 Management of document issuance, archival, and documentation compliance.

 Preparation and review of APQR/PQR reports.

 Handling Change Control, Deviations, CAPA, OOS, OOT, and Market Complaint investigations.

 Ensure implementation and adherence to SOPs, protocols, GMP, GDP, and regulatory guidelines.

 Coordination with cross-functional departments for smooth plant operations and compliance.

 Review and monitoring of Equipment Qualification and Validation activities.

 Vendor qualification and approval management.

 Handling hold time studies and IMS-related documentation.

Regulatory Affairs & Audit Management

 Coordination with international regulatory bodies, foreign delegates, customers, and inspection teams.

 Experience in handling regulatory audits such as USFDA, FDA, WHO, Cofepris, KFDA, ISO, and customer audits.

 Lead preparation and coordination for internal, external, customer, and certification audits.

 Ensure audit readiness and closure of observations through effective CAPA implementation.

 Strong understanding of ISO systems, quality management systems, and compliance frameworks.

 Support regulatory documentation, submissions, and responses during inspections.

Process Improvement & Systems

 Conduct Internal Quality Audits (IQA) and compliance reviews.

 Ensure all manufacturing and quality activities are executed as per approved 

procedures.

 Drive continuous improvement initiatives in quality systems.

 Familiarity with ERP/SAP systems and digital quality management systems.

Required Skills & Competencies

 Strong personality with leadership and ownership mindset.

 Excellent communication and coordination skills.

 Strong exposure to GMP, GDP, ISO standards, and regulatory compliance.

 Ability to handle audits confidently with international agencies and customers.

 Good analytical, investigation, and problem-solving skills.

 Proficiency in MS Office, documentation systems, and compliance reporting.

Preferred Industry Experience

 Experience in Chemical, Textile, API, Specialty Chemical, or regulated Manufacturing industries. 

 Hands-on exposure in regulated plants handling international regulatory audits, customer inspections, ISO audits, and compliance requirements. 

 Experience in coordinating with foreign delegates, certification bodies, and regulatory authorities will be preferred.