Officer – Quality Assurance

Job Description

• Visiting to DS manufacturing and warehouse facility to ensure that activities are being carried out by following GMP requirements, Regulatory requirement and as per approved procedures.
• To participate in the manufacturing investigation and CAPA finalization activity.

• Preparation and review the Risk Assessment and Mitigation Plan.
• Ensure that process and cleaning validation activities are being carried out by following approved protocols.
• Review of master document like study protocol, BPR, MFR etc.

• Review of executed Batch Processing Records for Batch Release.
• Review of Batch Dispatch Record and verification of dispatch activities in warehouse.
• Overall coordination for the APQR data compilation and APQR preparation activity.

• Preparation and review of Quality System SOPs & documents.
• Review of SOPs as per GMP requirements for all departments.

Work Experience

1- 3 YEARS

Education

Masters in Biotechnology or BiotechnologyPost Graduation in Biopharmaceutics or Pharmacy

Competencies

1. Strategic Agility2. Innovation & Creativity3. Customer Centricity