QA QC Executive

Role & responsibilities

QA Documentation

Preparation, review, control, and archival of SOPs, STPs, GTPs, Specifications, and Protocols.

Ensure compliance of documentation with cGMP, GLP, and regulatory requirements.

Handling of document control system including issuance, reconciliation, and retrieval.

Support audit readiness by maintaining updated quality documents.

Review of analytical reports, logbooks, and batch-related records.

QA Validation & Qualification

Execution of Equipment Qualification (IQ/OQ/PQ) for analytical instruments.

Preparation and review of validation protocols and reports for process and analytical methods.

Cleaning validation and utility qualification support.

Preparation of Validation Master Plan (VMP).

Coordination with QC and Engineering teams for validation activities as per regulatory guidelines.

Quality Management System (QMS)

Handling of deviations, CAPA, Change Control, OOS, and OOT investigations.

Conduct internal audits and ensure compliance with QMS requirements.

Risk assessment and root cause analysis for quality incidents.

Monitoring and trending of quality metrics.

Preparation and review of quality reports and audit documentation.

IPQA (In-Process Quality Assurance)

Line clearance and in-process checks during analytical and lab activities.

Monitoring of sample handling, testing procedures, and documentation practices.

Verification of compliance to SOPs and regulatory guidelines during operations.

Review of batch records and analytical test data.

Ensuring adherence to Good Laboratory Practices (GLP).

QC Instrumentation

Operation, calibration, and maintenance of analytical instruments such as HPLC, GC, UV, FTIR, etc.

Execution of analytical method validation and instrument qualification.

Preparation of calibration and maintenance records.

Troubleshooting of instruments and ensuring uptime.

Compliance with data integrity and regulatory standards.

QC Microbiology

Environmental monitoring and microbial testing.

Sterility testing, MLT, BET, and water analysis.

Media preparation and growth promotion testing.

Handling of microbial cultures and documentation.

Ensuring GLP compliance in microbiology laboratory operations.

Preferred candidate profile

Bachelors / Masters Degree in Pharmacy, Microbiology, Biotechnology, Chemistry

2–8 years of experience in QA/QC within a Pharma industry

Sound knowledge of cGMP, GLP, Data Integrity, and regulatory requirements.

• Experience

  2 - 8 Years

• No. of Openings

  5

• Education

  Graduate (B.Pharma, B.Sc)

• Role

  QA QC Executive

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  Male

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office