Quality Assurance Manager

2 days ago


Trenton, New Jersey, United States Aurobindo Pharma USA Full time
Job Title: Quality Control Director

At Aurobindo Pharma USA, we are seeking a highly skilled Quality Control Director to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our pharmaceutical production processes.

Key Responsibilities:
  • Develop and implement process validation plans to ensure compliance with regulatory requirements.
  • Optimize pharmaceutical production processes to improve efficiency and quality.
  • Develop and manage project plans and timelines to meet new product launches and process changes.
  • Execute post-approval change projects, including scale-ups and alternate source of excipients.
  • Formulate ANDA products for submission/exhibit batches that match brand drug release profiles.
  • Transfer and evaluate new/existing products from APL India and assess stability.
  • Develop and manage SOPs, training, and regulatory compliance.
  • Communicate with internal and external partners to explain study strategies and present research findings.
  • Provide data to regulatory departments for annual product reviews and support audits.
Requirements:
  • Master's degree in Chemistry, Chemical Engineering, Pharmaceutical Science, or Pharmacology.
  • Knowledge of technology transfer to manufacturing during process validation, formulation development of ANDA products, and monitoring compliance to cGMP.
What We Offer:

We offer a competitive annual wage of $80,600 and a Monday-Friday schedule from 8:00 AM to 5:00 PM.



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