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1 week ago
We are seeking an experienced professional to oversee the management and execution of qualification activities, encompassing preparation, review, and execution of various qualification documents.
Main Responsibilities- Supervise new project-related tests and reviews.
- Compile raw data and ensure compliance with validation master plans and Standard Operating Procedures (SOPs).
- Implement corrective and preventive actions.
- Conduct incident investigations.
- Provide support during regulatory inspections.
- A Master's degree in Pharmacy is mandatory.
- A minimum of 9 years of experience in working with sterile product facility related validations.
- Expertise in preparing, reviewing, and executing documents, including User Requirements Specifications (URS), Design Qualification (DQ), Functional Design Specification (FDS), Utility Test Matrix (UTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Requalification (RQ).
- Experience in handling incident investigations and CAPA processes.
- Experience in preparing and reviewing Validation Master Plans (VMP) and SOPs.
The Global Manufacturing Organisation (GMO) is dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation.
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