Amneal Pharmaceuticals

Assistant Manager, Quality Assurance - Validation

Amneal Pharmaceuticals Ahmedabad, Gujarat, India
Amneal Pharmaceuticals

Assistant Manager, Quality Assurance - Validation

Amneal Pharmaceuticals Ahmedabad, Gujarat, India
3 days ago 143 applicants

See who Amneal Pharmaceuticals has hired for this role

Job Description

The following are the key responsibilities for both the positions:

  • Lead the validation and qualification efforts for new equipment, facilities, and systems within the injectable plant, ensuring compliance with cGMP, FDA, and other relevant regulatory requirements.
  • Develop and implement comprehensive validation master plans, schedules, and strategies for the injectable manufacturing processes.
  • Oversee the preparation, review, and approval of validation protocols, reports, and other related documentation, ensuring accuracy and completeness.
  • Manage and mentor the validation team, providing guidance and training to ensure the effective execution of validation activities.
  • Collaborate with cross-functional departments, including production, quality assurance, engineering, and regulatory affairs, to ensure alignment and support for validation projects.
  • Drive continuous improvement initiatives within the validation and qualification processes, incorporating industry best practices and technological advancements.
  • Act as the primary point of contact for internal and external audits related to validation, addressing findings and implementing corrective actions as needed.
  • Ensure that all validation activities are completed within the required timelines to support the plant's production and regulatory submission schedules.

Qualifications

M. Pharm (10 Years Minimum)

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing

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