Validation Senior Supervisor At Hikma Pharmaceuticals
Responsible for writing protocols, conducting research into industry standards/FDA guidelines for validation equipment/processes, and making determinations regarding acceptance criteria and testing in order to prepare project schedules, execute validation studies, perform data analysis and write protocol summaries and reports while being in compliance with SOPs, GMPs and FDA requirements.
Duties & Responsibilities:
- Performs all validation and qualification activities for plant areas, including the preparation and execution of protocols, as well as collecting and analyzing the needed samples
- Calibrates and validates processes instruments and equipment to fulfill validation requirements according to the internal system and international guidelines
- Perform process validation for batches according to regulatory requirements
- Prepares written reports/summaries from validation studies in order to perform proper data analysis
- Documents and files internal and external scheduled validation field activities to ensure proper execution
- Liaises with external validation contractors in order to ensure conformance of activities to procedures and processes
- Maintain and order the needed CAPEX for the validation department
- Updates the company systems according to regulatory and quality standards, updated GXP standards and best practices related to validation scope of work
- Evaluates deviations which may occur during qualification in order to suggest proper solutions in coordination with the concerned departments
- Follow up with related deviations and CAPAs, ensuring the proper documentation and timely close up
- Coordinates and participates in technical and quality audit inspection programs to identify potential deficiencies and follow up on issues detected
- Reviews the qualification data and results to ensure compliance with protocol procedures and acceptance criteria
- Verifies the revalidation action when a maintenance requisition form is submitted to the validation department in order to modify the actions if needed
- Manages the approval/review of validation actions needed in order to requalify any equipment or system that is under modification or changes
- Evaluates the utilities and plant layouts to ensure that they are built in compliance with cGMP
- Manages the training for departments involved in the qualification activities in order to ensure optimal validation performance
- Establishes internal and external validation programs in order to increase the validation team’s awareness in the equipment and systems qualification processes
- Prepares and updates the Validation Master Plan in order to plan for validation activities with all concerned departments
- Bachelor’s degree in Pharmacy, Engineering, Science with preferably a master.
- Minimum Experience: 3-5 years of experience in a quality role preferably in validation, with at least 1 year of progressive leadership experience.
- Preferably (Cairo, Obour, New Cairo, Nasr City, Heliopolis, Badr, Zagazig, Sharqiyah, and 10th of Ramadan) residents