Executive, IPQA at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

02 Sep, 26

Salary

0.0

Posted On

04 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IPQA, GMP Compliance, Line Clearance, Data Integrity, Cleaning Validation, Process Validation, Aseptic Process Simulation, Deviation Management, 21 CFR Part 210 & 211, BMR/BPR Review, Environmental Monitoring, Good Documentation Practices, Quality Assurance, In-Process Quality Control, Audit Readiness, Pharmaceutical Manufacturing

Industry

Pharmaceutical Manufacturing

Description

Description: The role is responsible for ensuring day-to-day compliance with global GMP (Good Manufacturing Practices) during manufacturing, packing, and dispensing activities at the site. The role provides on-floor quality assurance support, ensuring operations are performed as per approved procedures, validated processes, and regulatory expectations. The role performs line clearance, in-process checks, routine area monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. The position supports cleaning validation, process validation, and aseptic process simulations, and assists in deviation management and inspection readiness, contributing to consistent, compliant, and right-first-time pharmaceutical manufacturing. Essential Functions: * Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations * Oversee calibration of IPQA instruments * Review of and release of Batch * Review the in-process and finished product COA before batch release * Keeping records & review of equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records * Execute Line Clearance and Readiness for manufacturing, packing, and dispensing areas * Conduct routine In-Process Checks and coordinate with IPQC (In-Process Quality Control) * Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs) * Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy * Perform Environmental Monitoring and routine monitoring of manufacturing areas * Ensure assurance of cleaning, sterilization, and aseptic manipulations * Support Sampling of Cleaning Validation and record compilation * Assist in Process Validation Reports (PVR – Process Validation Report) activities * Support Aseptic Process Simulation (Media Fill) monitoring * Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance * Participate in Routine GMP Inspections and quality record reviews 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.

Responsibilities

Responsible for ensuring day-to-day GMP compliance during manufacturing, packing, and dispensing activities. Performs line clearances, in-process checks, and documentation reviews to ensure product quality and patient safety.