Qa Analyst

Vaibhav Analytical Services; Ahmedabad District; Presencial; INR 450.000 - 600.000; Tempo integral

Resumo da vaga

Vaibhav Analytical Services in Ahmedabad is seeking a QA/QC professional with 1–2 years of experience to ensure GLP compliance and robust documentation in analytical testing. You will prepare and review SOPs, manage change controls, deviations, incidents, and CAPA, and maintain quality records for audits and regulatory inspections.

Key duties include SOP revision, CAPA initiation, deviation investigations, and GLP document reviews, ensuring adherence to regulatory requirements and internal

Qualificações

• B.Sc. or M.Sc. in Chemistry is required.
• 1–2 years of experience in pharmaceutical QA.
• Experience with SOPs, change controls, and CAPA.
• Knowledge of GLP documentation requirements.
• Strong written and verbal communication skills.

Responsabilidades

• Prepare, review, and revise SOPs in line with regulatory requirements and internal standards.
• Manage and monitor Change Control procedures from evaluation to documentation.
• Handle deviation management including investigations and CAPA follow-up.
• Record, investigate, and document incidents per quality procedures.
• Initiate and monitor CAPA to resolve quality issues effectively.
• Review GLP documents and laboratory records for accuracy and compliance.
• Ensure compliance with regulatory requirements and internal procedures.
• Maintain documentation to support audits and inspections.
• Coordinate with lab personnel to ensure adherence to approved procedures.

Conhecimentos

QA practices

Regulatory knowledge

SOP development

Change control

Deviation mgmt

CAPA

GLP review

Documentation

Analytical skills

Formação

B.Sc./M.Sc. Chemistry

Descrição da vaga

Job Description

Qualification: B.Sc/M.Sc Chemistry

Experience: 1 to 2 Years

Job Summary:

• Responsible for ensuring compliance with regulatory requirements and Good Laboratory Practices (GLP) within the pharmaceutical industry, particularly for analytical laboratory testing and documentation. The role involves preparation and review of Standard Operating Procedures (SOPs), management of change controls, deviations, incidents, and Corrective and Preventive Actions (CAPA), along with reviewing GLP-related documents to maintain quality standards and regulatory compliance.

Key Responsibilities:

• Prepare, review, and revise Standard Operating Procedures (SOPs) in accordance with applicable regulatory requirements and internal quality standards.
• Manage and monitor Change Control procedures to ensure proper evaluation, approval, implementation, and documentation of changes.
• Handle deviation management, including investigation, root cause analysis, documentation, and follow-up of corrective actions.
• Record, investigate, and document incidents in accordance with established quality procedures.
• Initiate, review, and monitor Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues.
• Review Good Laboratory Practice (GLP) documents and analytical laboratory records to ensure accuracy, completeness, and compliance.
• Ensure compliance with applicable regulatory requirements, quality management systems, and internal laboratory procedures.
• Maintain proper documentation and records to support internal audits, regulatory inspections, and quality assessments.
• Coordinate with laboratory personnel to ensure adherence to approved procedures and quality standards.
• Support continuous improvement initiatives to strengthen documentation practices and maintain a state of regulatory compliance.

Required Knowledge and Skills:

• Working knowledge of Quality Assurance practices in the pharmaceutical industry.
• Knowledge of regulatory requirements applicable to analytical laboratory testing and documentation.
• Experience in SOP preparation, review, and revision.
• Understanding of Change Control, Deviation Management, Incident Reporting, and CAPA procedures.
• Knowledge of GLP documentation review and compliance requirements.
• Good documentation, communication, analytical, and problem-solving skills.