QC Executive - Laboratory Documentation & GLP

Aviiral Medicare; Indore District; On-site; INR 500,000 - 800,000; Full time

Job summary

Aviiral Medicare in Indore seeks an experienced QC documentation specialist for a pharmaceutical setting. The role focuses on building and maintaining clear, controlled QC documents and ensuring laboratory records are complete, traceable and ready for review.

Routine testing may be assigned when required, but it is not the main focus of the position. Applicants should have strong experience writing and reviewing pharmaceutical QC documents, with confidence in GMP documentation, instrument

Qualifications

• Applicants should have strong experience writing and reviewing pharmaceutical QC documents.
• They should be confident with GMP documentation, instrument records, raw-data review and coordination with QA.
• Experience establishing a QC documentation system for a new facility is an advantage.

Responsibilities

• Draft, revise and maintain QC SOPs, raw-material and finished-product specifications, sampling procedures, test methods, worksheets, forms and registers.
• Coordinate document numbering, version control, periodic review, issuance and withdrawal with QA.
• Maintain sample receipt, sampling, testing, retention and disposal records.
• Maintain instrument master lists, usage logbooks, calibration schedules, calibration records, maintenance records and equipment status documentation.
• Maintain records for reference standards, working standards, reagents, volumetric solutions and laboratory inventory.
• Prepare and organize stability study protocols, sample records, chamber monitoring records, testing schedules and reports.
• Review analytical worksheets, chromatograms where applicable, calculations and supporting raw data for completeness, accuracy, traceability and compliance with approved procedures.
• Support documentation for instrument qualification, analytical method verification or validation, laboratory investigations, OOS/OOT results, deviations, CAPA and change controls.
• Track open QC documentation actions and follow up with analysts, QC management and QA to close gaps on time.
• Help prepare records for internal audits, regulatory inspections and customer audits.
• Follow good laboratory practices, data-integrity principles and contemporaneous recording requirements.

Skills

QC documentation

GMP knowledge

Record keeping

Data integrity

Education

B.Pharm / M.Pharm

BSc / MSc Chemistry

Job description

Experience: 2-5 years in pharmaceutical QC documentation

Qualification: B. Pharm, M. Pharm, B.Sc. or M.Sc. in Chemistry or a relevant discipline

Role overview

This is primarily a documentation and laboratory systems role, reporting to the QC Head. We need someone who can build and maintain clear, controlled QC documents and ensure laboratory records are complete, traceable and ready for review. Routine testing may be assigned when required, but it is not the main focus of the position.

Key responsibilities

• Draft, revise and maintain QC SOPs, raw-material and finished-product specifications, sampling procedures, test methods, worksheets, forms and registers.
• Coordinate document numbering, version control, periodic review, issuance and withdrawal with QA.
• Maintain sample receipt, sampling, testing, retention and disposal records.
• Maintain instrument master lists, usage logbooks, calibration schedules, calibration records, maintenance records and equipment status documentation.
• Maintain records for reference standards, working standards, reagents, volumetric solutions and laboratory inventory.
• Prepare and organize stability study protocols, sample records, chamber monitoring records, testing schedules and reports.
• Review analytical worksheets, chromatograms where applicable, calculations and supporting raw data for completeness, accuracy, traceability and compliance with approved procedures.
• Support documentation for instrument qualification, analytical method verification or validation, laboratory investigations, OOS/OOT results, deviations, CAPA and change controls.
• Track open QC documentation actions and follow up with analysts, QC management and QA to close gaps on time.
• Help prepare records for internal audits, regulatory inspections and customer audits.
• Follow good laboratory practices, data-integrity principles and contemporaneous recording requirements.

Candidate profile

Applicants should have strong experience writing and reviewing pharmaceutical QC documents, rather than only performing laboratory tests. They should be confident with GMP documentation, instrument records, raw-data review and coordination with QA. Experience establishing a QC documentation system for a new facility is an advantage.