Assoc, Quality Control - Qms Job in Baxter International

Role Overview:

We are seeking a Quality Assurance Professional to ensure the effective implementation and maintenance of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within our operations. This role will support the Quality Control (QC) lab and work closely with the Quality Assurance (QA) team to uphold high-quality standards in all processes and procedures.

Key Responsibilities:

• Deviation Management: Review, update, and report any deviations to the Supervisor. Ensure proper documentation and root cause analysis in line with standard operating procedures (SOPs).

• NCR Recording: Oversee the recording of Non-Conformance Reports (NCRs) ensuring adherence to SOPs and compliance requirements.

• GMP and GDP Compliance: Ensure the implementation of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in all relevant processes. Evaluate the impact of any identified issues and implement corrective actions as needed.

• GLP Rounds: Conduct Good Laboratory Practice (GLP) rounds within the Quality Control lab to ensure compliance with established standards.

• Training & Development: Train and update team members on relevant regulatory guidelines and GMP best practices.

• Deviation and Abnormality Management: Identify and monitor deviations or abnormalities in processes, documentation, and systems. Resolve issues in accordance with the Quality Management System (QMS).

• Reporting: Ensure timely reporting of all deviations, Out of Specification (OOS) results, and other quality-related issues to the QA team.

• SOP Management: Review, update, and implement SOPs to reflect current regulations and best practices.

• Technical Committee Meetings: Lead and conduct Technical Committee Meetings to assess the impact of Change Control Notes (CCN).

• CAPA Management: Conduct monthly Corrective and Preventive Action (CAPA) meetings. Review the CAPA summary report to ensure timely closure of all action items.

• Change Control & NCR Review: Review Change Control Notes and NCR reports before submission to the Quality Committee for final approval and closure.

• QMS Investigation: Investigate quality management system elements and ensure they are addressed and closed within required timelines.

Qualifications:

• Experience: Proven experience in quality assurance or quality control in a regulated manufacturing environment.

• Knowledge: Strong understanding of GMP, GDP, and GLP standards and regulatory guidelines.

• Skills: Strong analytical skills, attention to detail, and problem-solving capabilities.

• Training: Ability to train and mentor team members on quality-related practices and regulatory requirements.

• Documentation: Familiarity with SOP creation and review, along with experience in handling CAPA, NCR, and OOS processes.