Sr Exec, Quality Control Job in Baxter International

Core Responsibilities:

• Quality Assurance:
  • Ensure adherence to GMP, GLP, and GDP standards.
  • Conduct regular audits and inspections to identify and address compliance gaps.
  • Implement corrective and preventive actions (CAPA) to mitigate risks and improve processes.
• Laboratory Operations:
  • Manage and maintain laboratory equipment and instruments.
  • Perform routine calibration and maintenance tasks.
  • Ensure data integrity and accuracy in laboratory records.
• Regulatory Compliance:
  • Stay up-to-date with regulatory requirements and industry standards.
  • Support regulatory audits and inspections.
  • Prepare and review SOPs and other regulatory documents.
• Incident Management:
  • Investigate OOS, OOT, and other deviations.
  • Conduct root cause analysis and implement corrective actions.
• Team Management:
  • Train and mentor team members on GMP, GLP, and GDP.
  • Collaborate with cross-functional teams to ensure smooth operations.

Specific Tasks:

• Procurement and installation of analytical instruments.
• Training team members on GMP, GDP, and GLP.
• Participating in investigations and CAPA implementation.
• Supporting external audits and responding to audit observations.
• Performing gap assessments and implementing corrective actions.
• Maintaining laboratory facilities and equipment.
• Ensuring data integrity and compliance with regulatory requirements.