Quality Assurance Executive

Biopharm Group

5 years

0 Lacs

Nelamangala Karnataka India

Posted:3 days ago| Platform:

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Skills Required

compliance manufacturing controls documentation packaging checks monitoring risk coordination audits data integrity qc communication audit trackwise lims

Work Mode

On-site

Job Type

Full Time

Job Description

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About the Company:

QA Executive

Role Overview:

The QA Executive will play a critical role in ensuring product quality and regulatory compliance across all stages of manufacturing. The candidate will be actively involved in quality systems, in-process controls, documentation review, and regulatory readiness.

Key Responsibilities:

Review and approval of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR)
Execution and review of process validation, cleaning validation, and hold time studies
Line clearance, in-process checks, and compliance monitoring on the shop floor
Handling deviations, CAPA, change controls, and quality risk management
Coordination for internal audits, regulatory inspections, and customer audits
Oversight of document control and SOP implementation
Ensuring adherence to cGMP, GDP, and data integrity practices
Supporting cross-functional teams including production, QC, and RA

Required Qualifications & Skills:

B.Pharm / M.Pharm / M.Sc (Chemistry or related discipline)
2 to 5 years of relevant experience in QA within an pharmaceutical manufacturing setup
Sound understanding of regulatory guidelines (USFDA, EU-GMP, WHO-GMP, etc.)
Strong documentation and communication skills
Proficient in handling QMS activities and audit preparedness
Familiarity with electronic systems like TrackWise, LIMS is an advantage

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