Executive, IPQA

Amneal Pharmaceuticals LLC; Ahmedabad District; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

Amneal Pharmaceuticals LLC seeks an IPQA professional to ensure day-to-day GMP compliance on the manufacturing floor, covering manufacturing, packing and dispensing activities. You will provide on-floor quality assurance support, review procedures, and ensure data integrity for patient safety.

The role includes line clearance, in-process checks, environmental monitoring, COA reviews, and regulatory alignment with 21 CFR Part 210 & 211, contributing to right-first-time pharmaceutical production.

Competenze

• B. Pharm required for the role.
• M. Pharm preferred for advanced qualifications.
• Experience of 1 year or more in 1–4 years.

Mansioni

• Perform IPQA activities during manufacturing and packing operations.
• Oversee calibration of IPQA instruments.
• Review of and release of Batch.
• Review in-process and finished product COA before batch release.
• Maintain records and review equipment logs and environmental monitoring records.
• Execute Line Clearance and Readiness for manufacturing, packing and dispensing areas.
• Ensure 21 CFR Part 210 & 211 compliance.
• Review BMR and BPR for accuracy.
• Perform Environmental Monitoring and routine monitoring of manufacturing areas.
• Support cleaning, sterilization and aseptic manipulations.
• Assist in Process Validation Reports and aseptic process simulations.
• Ensure Good Documentation Practices and participate in GMP inspections.

Conoscenze

IPQA Activities

GMP Compliance

Documentation Review

Batch Review

Formazione

B. Pharm

M. Pharm

Descrizione del lavoro

JOB 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.

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.

QUALIFICATIONS

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 1 year or more in 1 - 4 Years

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.