Amneal Pharmaceuticals Hiring for Quality Assurance (IPQA, QMS, Validation)

Amneal Pharmaceuticals LLC; Gujarat; Vor Ort; INR 600.000 - 1.200.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals invites qualified professionals to join their Quality Assurance (IPQA, QMS, Validation) team at the Palli-Kadi Plant in Gujarat. The role targets individuals with 2–7 years of experience in injectable facilities and strong regulatory compliance know-how.

You will oversee line clearance, validation activities, and QMS processes, supporting regulatory inspections and CAPA loops to ensure high-quality medicinal products.

Qualifikationen

• 2-7 years in an injectable regulated plant
• Exposure to terminally sterilized or aseptic-filled products
• Hands-on with deviation management, change control, CAPA
• Experience with market complaints and risk assessment
• Familiarity with global regulatory standards and audit readiness

Aufgaben

• Process Oversight: perform line clearance, in-process checks, and batch sampling; review batch docs for accuracy.
• Validation Expertise: conduct process validation, cleaning validation, hold time studies; oversee verification for regulatory compliance.
• Regulatory Compliance: manage QMS activities incl. deviation, CAPA, change control; prepare for USFDA/EU/MHRA inspections.

Kenntnisse

IPQA

Validation

QMS

Deviation Mgmt

CAPA

Change Control

Audit Prep

Regulatory Knowledge

Ausbildung

B.Pharm

M.Pharm

Jobbeschreibung

Amneal Pharmaceuticals, a global leader in the pharmaceutical industry with a workforce of over 7,500 professionals, is seeking talented individuals for Quality Assurance (IPQA, QMS, Validation) roles at their Palli-Kadi Plant. If you have 2-7 years of experience in an injectable facility and expertise in regulatory compliance, this is your opportunity to join a reputed organization renowned for its innovative and high-quality medicine portfolio.

Vacancy Details

Department:

• Quality Assurance (QA) – IPQA, Validation, and QMS.

Designations:

• Officer to Senior Executive.

Location:

• Palli-Kadi Plant, Gujarat.

Educational Qualification:

• B. Pharm or M. Pharm.

Experience Required:

• 2-7 years in an injectable regulated plant with exposure to terminally sterilized or aseptic-filled products.
• Hands-on experience with deviation management, change control, CAPA, market complaints, and risk assessment.

Key Responsibilities

1. Process Oversight
   • Perform line clearance, in-process checks, and batch sampling.
   • Review batch manufacturing and packing documents to ensure accuracy.
2. Validation Expertise
   • Conduct process validation, cleaning validation, and hold time studies.
   • Oversee verification activities to ensure regulatory compliance.
3. Regulatory Compliance
   • Manage QMS activities including deviation, CAPA, and change control.
   • Prepare for and participate in regulatory audits such as USFDA, EU, and MHRA inspections.

Required Skills

• Proficiency in quality assurance processes related to injectable products.
• Strong knowledge of validation protocols and documentation.
• Familiarity with global regulatory standards and audit requirements.
• Attention to detail and ability to handle market complaints and risk assessments effectively.