Senior Executive, IPQA EM

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

RXinsider LTD. in Ahmedabad District, India, seeks an IPQA professional to ensure compliance with cGMP on manufacturing and packaging floors. You will perform in-process quality assurance activities, document reviews, sampling, and area/machine clearances to support the production of high-quality injectable products.

Responsibilities include real-time monitoring, GMP training, investigations, and maintaining audit-ready IPQA records while ensuring accurate communication in English.

Qualifications

• Master degree in Microbiology or related field required.
• 2+ years of IPQA/IPQC experience in pharma manufacturing.
• Knowledge of cGMP/regulatory requirements.

Responsibilities

• Real-time monitoring and compliance reporting on the shop floor.
• Review of batch records, logs, and calibration records.
• Conduct sampling of reserve and in-process checks per BPR and stability protocol.
• Issue clearances for machines, areas, and labeling activities.
• Train shop floor personnel on GMP practices and documentation.

Skills

IPQC Mastery

Regulatory Knowledge

Aseptic Process Monitoring

Line Clearance

Deviation Investigation

In-Process Checks

Change Control

Equipment Knowledge

Root Cause Analysis

Analytical QA

Education

Master Degree (MS/MA) M. Sc - Microbiology

Job description

JOB DESCRIPTION

To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area/machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products

Essential Functions

• To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
• To supervision of dispensing activity of manufacturing shop floor and packing areas.
• To Issuance of Bottle label, Ouster and Medication guide for commercial batch.
• Rsponsible for providing machine and area clearance.
• To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol.
• Online Documents and records review like equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
• Calibration of IPQA instruments.

Additional Responsibilities

• Real-time Monitoring and Compliance Reporting.
• Participation in Investigations.
• Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
• Maintain IPQA-related documents and records in a state of audit readiness.
• To have good written and verbal communication skills in English language.

Qualifications

Education :

• Master Degree (MS/MA) M. Sc - Microbiology

Experience

• 2 years or more in 2 - 4 Years

Skills

• In-Process Quality Control (IPQC) - Mastery
• Compliance and Regulatory Knowledge - Advanced
• Aseptic Process Monitoring & Compliance - Advanced
• Line Clearance & Batch Record Review - Mastery
• Deviation, Investigation & CAPA Management - Advanced
• In-Process Checks & Monitoring - Advanced
• Deviation & Change Control Management - Advanced
• Equipment & Facility knowledge - Advanced
• Investigation Skills for Root Cause Analysis - Advanced
• Analytical Quality Assurance - Advanced