Quality Assurance Incharge

VASUDHA PHARMA CHEM; Hyderabad; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

VASUDHA PHARMA CHEM in Hyderabad is seeking a senior QA professional to lead Quality Management Systems, investigations, and regulatory compliance for APIs and bulk drug manufacturing. You will mentor QA staff, drive CAPA effectiveness, and ensure timely batch release in line with global regulatory standards.

The role requires extensive knowledge of cGMP, ICH, USFDA, EU GMP, and WHO GMP, with proven experience in audits and validation activities.

Qualifications

• Strong knowledge of cGMP, ICH Guidelines, USFDA, EU GMP, WHO GMP.
• Expertise in Deviation, CAPA, Change Control, OOS/OOT, and Risk Management.
• Experience in handling regulatory and customer audits.
• Knowledge of Data Integrity requirements and quality systems.
• Proficiency in documentation review and batch release processes.
• Good analytical, leadership, communication, and problem-solving skills.

Responsibilities

• Lead Quality Management System (QMS) activities including Deviations, CAPA, Change Controls, OOS/OOT investigations, Risk Assessments, and SOP management.
• Ensure compliance with cGMP, ICH, USFDA, EU GMP, WHO GMP, and other regulatory requirements.
• Review and approve quality documents, protocols, reports, and GMP records.
• Review Batch Manufacturing Records (BMR), Batch Production Records (BPR), cleaning records, and supporting documentation.
• Ensure timely batch disposition and release of APIs and intermediates.
• Verify compliance of manufacturing activities with approved procedures.
• Lead investigations for deviations, OOS, OOT, customer complaints, and market complaints.
• Perform root cause analysis and implement effective CAPAs.
• Monitor CAPA effectiveness and timelines.
• Review and approve validation documents related to Process, Cleaning, Equipment IQ/OQ/PQ, Analytical Method, and Computer System Validation.
• Ensure validation activities comply with regulatory expectations.
• Participate in and support regulatory inspections, customer audits, and internal audits.
• Prepare responses to audit observations and ensure closure of commitments.
• Conduct GMP audits and self-inspections.
• Ensure adherence to ALCOA+ and Data Integrity principles.
• Review GMP documentation for completeness and compliance.
• Support electronic and paper-based documentation control systems.
• Conduct GMP, Data Integrity, and Quality System training programs.
• Mentor junior QA personnel and support cross-functional teams.
• Drive quality culture initiatives across the organization.

Skills

cGMP knowledge

ICH Guidelines

USFDA

EU GMP

WHO GMP

CAPA & Change Control

OOS/OOT investigations

Audit readiness

Data Integrity

Documentation review

QA leadership

Tools

TrackWise

SAP

Veeva

MasterControl

Job description

Key Responsibilities

Quality Management Systems

• Manage and review Quality Management System (QMS) activities including Deviations, CAPA, Change Controls, OOS/OOT investigations, Risk Assessments, and SOP management.
• Ensure compliance with cGMP, ICH, USFDA, EU GMP, WHO GMP, and other applicable regulatory requirements.
• Review and approve quality documents, protocols, reports, and GMP records.

Batch Review & Product Release

• Review Batch Manufacturing Records (BMR), Batch Production Records (BPR), cleaning records, and supporting documentation.
• Ensure timely batch disposition and release of APIs and intermediates.
• Verify compliance of manufacturing activities with approved procedures.

Investigation & Compliance

• Lead investigations for deviations, OOS, OOT, customer complaints, and market complaints.
• Perform root cause analysis and implement effective CAPAs.
• Monitor CAPA effectiveness and compliance timelines.

Validation & Qualification

• Review and approve validation documents related to:
• Process Validation
• Cleaning Validation
• Equipment Qualification (IQ/OQ/PQ)
• Analytical Method Validation
• Computer System Validation
• Ensure validation activities comply with regulatory expectations.

Audit Management

• Participate in and support regulatory inspections, customer audits, and internal audits.
• Prepare responses to audit observations and ensure timely closure of commitments.
• Conduct GMP audits and self-inspections.

Documentation & Data Integrity

• Ensure adherence to ALCOA+ and Data Integrity principles.
• Review GMP documentation for completeness and compliance.
• Support electronic and paper-based documentation control systems.

Training & Team Management

• Conduct GMP, Data Integrity, and Quality System training programs.
• Mentor junior QA personnel and support cross-functional teams.
• Drive quality culture initiatives across the organization.

Required Skills

• Strong knowledge of cGMP, ICH Guidelines, USFDA, EU GMP, WHO GMP regulations.
• Expertise in Deviation, CAPA, Change Control, OOS/OOT, and Risk Management.
• Experience in handling regulatory and customer audits.
• Knowledge of Data Integrity requirements and quality systems.
• Proficiency in documentation review and batch release processes.
• Good analytical, leadership, communication, and problem-solving skills.

Preferred Experience

• Minimum 10 years in Quality Assurance within API/Bulk Drug manufacturing.
• Exposure to USFDA, EDQM, PMDA, MHRA, TGA, and WHO-regulated facilities.
• Experience in TrackWise, SAP, Veeva, MasterControl, or similar QMS platforms.
• Successful participation in regulatory inspections and customer audits.