Quality Assurance Executive

2 weeks ago

Mumbai, India Zeno Health Full time

Job Description:

We are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team. This individual will be responsible for ensuring the highest standards of quality control and regulatory compliance across various aspects of our operations. The key responsibilities for this role include:


Key Responsibilities:


· Develop, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements and company standards.

· Conduct training sessions for stakeholders on the proper implementation and adherence to quality-related SOPs.

· Manage the handling, maintenance, and archiving of quality assurance documents to ensure compliance and traceability.

· Review and ensure the accuracy and compliance of validation protocols, test reports, and related documentation.

· Review Batch Manufacturing Records (BMR) and Annual Product Quality Reviews (APQRs) for accuracy, completeness, and regulatory compliance.

· Review product specifications, methods of analysis (MOA), batch analysis data, and Certificates of Analysis (COAs) to ensure quality and compliance with established standards.

· Prepare and review stability schedules, ensuring timely execution and accurate reporting of stability studies.

· Develop and manage vendor audit schedules and track the progress of vendor qualification activities to ensure compliance with quality standards.

· Handle key aspects of the QMS, including Change Control, Deviations, Corrective and Preventive Actions (CAPA), Out-of-Specification (OOS), and Out-of-Trend (OOT) investigations.

· Coordinate with manufacturers for QMS documentation, stability data, BA/BE study reports, and Batch/Manufacturing Records (MFRs/BMRs/BPRs).

· Oversee the handling and investigation of product complaints, ensuring timely resolution and corrective actions.

· Support the implementation and tracking of ARWOTK (Analysis, Risk, Warning, Observation, Test, Knowledge) management for quality control.

· Assist with regulatory affairs-related activities, ensuring compliance with industry regulations and standards.


Key Skills:

  • Strong English communication and drafting skills.
  • Expertise in Pharmaceutical IPQA and manufacturing QA processes.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Strong understanding of QMS and QA documentation.

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