QA Analyst

Overview

Job Title

Quality Assurance (QA) Documentation Executive

Department- Quality Assurance (QA)

Geography Covered- Panoli Plant, Gujarat, India

Reports To: Direct: QA Manager - Matrix: Head of Quality & Compliance

Job Summary

The QA Documentation Executive is responsible for ensuring all quality-related documents, records, and compliance materials are properly maintained, updated, and aligned with industry standards and regulatory requirements. This role plays a critical part in supporting audits, implementing quality procedures, and fostering a compliance-driven culture.

General Duties & Responsibilities

Document Control & Compliance: Manage, review, and update QA documents, SOPs, batch records, and test reports.
Regulatory Compliance: Ensure adherence to ISO, GMP, FDA, and other chemical industry regulations.
Audit Preparation: Organize and maintain documentation for internal & external audits.
Training Support: Assist in training employees on document control and compliance standards.
Data Integrity & Security: Safeguard quality data and maintain version control.

Key Result Areas (KRAs) & Description

Document Control & Management – Maintain up-to-date and error-free QA documents, ensuring version control.
Regulatory Compliance – Ensure all documents comply with legal and industry standards (ISO, GMP, FDA, etc.).
SOP Development & Maintenance – Develop, review, and standardize Standard Operating Procedures (SOPs).
Internal & External Audits – Prepare QA documentation and ensure readiness for audits.
Training & Awareness – Conduct periodic training sessions on documentation standards and compliance.
Change Control Process – Manage and document changes in processes and regulations.
Non-Conformance & CAPA Documentation – Maintain records of non-conformities and track Corrective and Preventive Actions (CAPA).
Quality Review & Approvals – Support QA/QC teams in reviewing batch records, test reports, and deviations.
Continuous Improvement – Identify areas for improvement and implement best practices in documentation.

Data Integrity & Security – Ensure the confidentiality and security of quality-related records.

Key Performance Indicators (KPIs) & Description

Document Accuracy (%) – Percentage of QA documents without errors or missing information.
Regulatory Compliance Score – Measured through audit scores and adherence to industry regulations.
SOP Update Frequency (%) – Timely review and update of SOPs per schedule.
Audit Readiness Level (%) – Number of successful internal and external audits with minimal non-conformances.
Training Completion Rate (%) – Percentage of employees trained on documentation protocols.
Change Control Efficiency (%) – Time taken to document and implement approved changes.
CAPA Closure Rate (%) – Percentage of Corrective and Preventive Actions closed within the target timeline.
Quality Review Turnaround Time (TAT) – Time taken to review and approve documents.
Error Reduction in Documentation (%) – Decrease in document-related errors year-over-year.
Data Integrity Compliance (%) – Compliance with data security and integrity protocols.

Competency Metrics (KASH Model)

Knowledge (K): Regulatory guidelines (ISO, GMP, FDA), Document Management System (DMS), SOPs, Audit processes.
Attitude (A): Attention to detail, Compliance-oriented, Team player, Proactive approach.
Skill (S): Technical writing, Document control, Data analysis, Audit preparation.
Habit (H): Consistency in documentation, Accuracy, Timeliness, Ethical compliance.

Education & Experience

Education:
Bachelor's/master’s degree in chemistry, Chemical Engineering, Pharmacy, Microbiology, or related field.

Experience:
3-5 years of experience in QA documentation, regulatory compliance, and audit preparation in the chemical industry.

Technical Proficiency:
Familiarity with ERP, DMS, QMS software, and proficiency in MS Office (Excel, Word, PowerPoint).

Job Type: Full-time

Pay: ₹137,552.37 - ₹347,186.24 per year

Benefits:

• Health insurance
• Life insurance
• Provident Fund

Schedule:

• Day shift
• Morning shift
• Rotational shift

Supplemental Pay:

• Performance bonus
• Yearly bonus

Work Location: In person

Speak with the employer
+91 9586274866
Application Deadline: 15/03/2025
Expected Start Date: 13/03/2025