Quality Assurance Job at Amneal Pharmaceuticals | Apply Now
Amneal careers include a Quality Assurance opportunity for aspiring professionals at Amneal Pharmaceuticals. The organization is seeking a qualified candidate for a role focused on ensuring compliance with global Good Manufacturing Practices (GMP) at their manufacturing site. Additionally, interested candidates should apply before the deadline.
About The Company
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to providing high-quality generic and specialty medicines. With a commitment to innovation and patient care, Amneal operates in various therapeutic areas and is known for its focus on quality and compliance in all manufacturing processes. The company aims to improve patient outcomes through its extensive portfolio of medications.
- Position: Quality Assurance Role
- Job ID: 8828
- Location: Ahmedabad City, Gujarat
Amneal Careers: Job Description
Within Amneal Pharmaceuticals careers, 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. Moreover, the role performs line clearance, in-process checks, routine area monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. Additionally, 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.
Key Responsibilities
- Perform IPQA (In-Process Quality Assurance at Amneal) activities during manufacturing and packing operations.
- Oversee calibration of IPQA instruments.
- Review and release Batch.
- Review the in-process and finished product COA before batch release.
- Keep 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.
Amneal careers: Eligibility Criteria
- Education: B. Pharm – Required; M. Pharm – Preferred.
- Experience: 1 year or more in 1 – 4 Years.
This Amneal careers opportunity presents a significant step for those looking to advance their careers in quality assurance within the pharmaceutical industry. Qualified candidates are encouraged to apply before the deadline to seize this opportunity.
