Qa Analyst

CIEL HR; Dahej; On-site; INR 700,000 - 1,100,000; Full time

Job summary

CIEL HR in Dahej, Gujarat, seeks a QA Analyst with 4–10 years in QA processes in pharma or chemical manufacturing. The candidate should have strong QMS exposure and hands-on experience with deviations, CAPA, Change Control, and BMR review.

The role involves document control, root cause analysis, quality risk assessments, and audits while ensuring GMP/GDP and data integrity. Reporting to the Quality Manager, a M.Sc. with QMS Lead Auditor certification is preferred.

Qualifications

• M.Sc. + 4-10 years QA experience in pharma/chemical manufacturing.
• Strong exposure to QMS and quality systems.
• Experience handling deviations, CAPA, Change Control, and QRA.

Responsibilities

• Review Batch Manufacturing Records (BMR) and production documents.
• Control SOPs, forms, specifications and records.
• Manage Deviation, Incident, Non-Conformance, CAPA, and Change Control.
• Conduct Root Cause Analysis (RCA) and verify CAPA effectiveness.
• Perform Quality Risk Assessments (QRA).
• Ensure GMP, GDP, ALCOA+, and Data Integrity compliance.
• Audit internal, customer, supplier, and regulatory processes.
• Lead Management Review Meetings and action tracking.
• Maintain QA training records and evaluate effectiveness.
• Support qualification, validation, and verification activities.
• Assist customer complaint investigations and corrective actions.
• Drive QMS continual improvements.
• Depose for the Quality Manager when required.

Skills

QA process/operations

Audit understanding

CAPA

QMS exposure

Education

M.Sc.

QMS Lead Auditor certification

Job description

QA Analyst Short JD / Screening Points

• Location: Dahej, Gujarat
• Reporting: Quality Manager
• Experience: 4-10 years in QA Process/Operations
• Industry: Pharma or Chemical companies
• Qualification: M.Sc.
• Certification: QMS Lead Auditor preferred/required

Key Responsibilities

• Batch Manufacturing Record (BMR) and production document review.
• SOP, forms, specifications and record document control.
• Handling Deviation, Incident, Non-Conformance, CAPA and Change Control.
• Conduct Root Cause Analysis (RCA) and CAPA effectiveness checks.
• Perform Quality Risk Assessments (QRA).
• Ensure compliance with GMP, GDP, ALCOA+, Data Integrity.
• Compliance with IMS, EFfCI, EXCiPACT GMP, Halal, Kosher and applicable standards.
• Conduct/support internal, customer, supplier and regulatory audits.
• Handle Management Review Meetings and action tracking.
• Manage QA training records and effectiveness evaluation.
• Support qualification, validation and verification activities.
• Support customer complaint investigations and corrective actions.
• Drive QMS continual improvement.
• Deputize for the Quality Manager when required.

Must-Have Candidate Profile

M.Sc. + 4-10 years QA experience + Pharma/Chemical manufacturing + strong QMS exposure, particularly:

Deviation | CAPA | Change Control | QRA | BMR Review | Document Control | GMP/GDP | ALCOA+ | Data Integrity | Audits | RCA