Quality Operations Expert

2 weeks ago

Hyderabad, Telangana, India beBeeQuality Full time US$ 7,50,000 - US$ 15,00,000

Job Description:

We are seeking a skilled Quality Operations Specialist to join our team. In this role, you will be responsible for providing quality services in compliance with cGMP requirements and our Quality Management System. You will manage quality aspects projects within your area of responsibility, ensuring that all tasks are completed efficiently and effectively.

About the Role:

  • Coordinate and manage analytical method transfers and stability studies
  • Compile data reports
  • Lifecycle management of analytical methods, including control of method performance, pharmacopoeia, and health authority compliance
  • Handling of deviations, investigation, OOS, OOE, OOT cases, as well as changes and complaints
  • Perform statistical data analysis to report Out of Expectations (OEE), out of trends, etc.
  • SAP master data management, maintenance of master data, creation of Q-info records, and other SAP-related activities
  • Validate spreadsheets, collect, transcribe, and compile data from various repositories, SAP, LIMS, external COAs
  • Author, approve, and archive
  • Impurity risk assessments - Nitrosamines, residual solvents, etc.
  • Trend and report all QMS elements as per the request
  • Monitor, trend, and report Health Safety and Environmental parameters

Required Skills and Qualifications:

We require a highly motivated individual with strong analytical skills and experience in Quality Assurance or Regulatory. The ideal candidate will have a Pharmacy, Science, MBA, or Engineering degree from a reputable institute and at least 3 years of experience in Quality Assurance, Regulatory, or manufacturing of pharmaceutical drug substances, products, medical devices. GxP knowledge and basic IT skills are essential.

Benefits:

You will receive a competitive salary and benefits package, including continuous learning opportunities, dealing with ambiguity, and technological expertise. Our purpose is to reimagine medicine to improve and extend people's lives.

Join Our Team:

If you are passionate about quality and want to make a difference, apply now Join our network to stay connected and hear more about our career opportunities.

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