Analytical Quality Assurance (AQA)

Maya Biotech; Solan; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Maya Biotech in Solan, Himachal Pradesh, seeks an experienced Analytical Quality Assurance (AQA) professional to ensure QC laboratory activities comply with cGMP, GLP, GDP, Data Integrity (ALCOA+), SOPs and regulatory requirements. Focus areas include data review, OOS/OOT investigations, audit trails, CAPA, calibration and qualification compliance, and inspection readiness.

The role involves reviewing OOS/OOT, laboratory incidents, deviations and CAPA; performing raw data reviews; conducting

Qualifications

• Strong knowledge of OOS/OOT investigations, Data Integrity, ALCOA+, Audit Trail Review, CAPA, Deviations, and Change Control.
• Experience with analytical instruments used in QC/QA labs such as HPLC, UPLC, GC, UV, FTIR, and dissolution testing.
• Familiarity with WHO-GMP, US FDA, EU GMP, 21 CFR Part 11, Annex 11, and ICH guidelines.

Responsibilities

• Review and investigate OOS, OOT, laboratory incidents, deviations, and CAPA.
• Perform analytical raw data review, chromatogram review, and documentation verification.
• Conduct audit trail reviews and ensure Data Integrity compliance.
• Review calibration, qualification, maintenance, and computerized systems.
• Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.
• Support change controls, risk assessments, and lab compliance monitoring.
• Participate in internal, customer, and regulatory audits and maintain inspection readiness.
• Monitor quality metrics and trend analysis for recurring issues.
• Conduct training on OOS/OOT, Data Integrity, GDP, GMP, and investigations.

Skills

OOS/OOT investigations

Data Integrity ALCOA+

Audit Trail Review

CAPA

Change Control

Tools

HPLC

UPLC

GC

UV

FTIR

Dissolution

TOC

ICP

Karl Fischer

Job description

We are seeking an experienced Analytical Quality Assurance (AQA) professional to ensure compliance of QC laboratory activities with cGMP, GLP, GDP, Data Integrity (ALCOA+), SOPs, and regulatory requirements. The role will focus on analytical data review, OOS/OOT investigations, audit trail review, CAPA management, calibration and qualification compliance, and inspection readiness.

Key Responsibilities

• Review and investigate OOS, OOT, laboratory incidents, deviations, and CAPA.
• Perform analytical raw data review, chromatogram review, and verification of laboratory documentation.
• Conduct audit trail reviews and ensure compliance with Data Integrity (ALCOA+) requirements.
• Review calibration, qualification, maintenance, and computerized system compliance activities.
• Ensure compliance with cGMP, GLP, GDP, pharmacopoeial requirements, and regulatory guidelines.
• Support change controls, risk assessments, and laboratory compliance monitoring.
• Participate in internal, customer, and regulatory audits and maintain inspection readiness.
• Monitor quality metrics, trend analysis, and recurring compliance issues.
• Conduct training and awareness programs on OOS/OOT, Data Integrity, GDP, GMP, and laboratory investigations.

Required Skills

• Strong knowledge of OOS/OOT investigations, Data Integrity, ALCOA+, Audit Trail Review, CAPA, Deviations, and Change Control.
• Hands-on experience with analytical instruments such as HPLC, UPLC, GC, UV, FTIR, Dissolution, TOC, ICP, and Karl Fischer.
• Knowledge of WHO-GMP, US FDA, EU GMP, 21 CFR Part 11, Annex 11, and ICH guidelines.
• Strong analytical, documentation, investigation, and problem-solving skills.
• Experience in pharmaceutical QC/QA laboratory compliance and regulatory inspections.