1.0Assisting the manager and assistant manager to achieve the department Job function.
2.0Preparing, reviewing and approving qualification/ re-qualification protocols and reports, coordinating the work with other departments and executing the qualification/ re-qualification protocol.
3.0Participating in achieving the calibration requirements for the qualification process.
4.0Generating, reviewing and approving Validation Department SOPs and reviewing and approving the SOPs and Documents of other departments.
5.0Determining the actions to be taken when a SAP job work order is submitted to validation department.
6.0Evaluating and approving the change controls submitted to validation department.
7.0Ensuring all validation and calibration documents and activities are complying with the current Good Manufacturing Practices (cGMP).
8.0Participating in the machine/ system purchasing (if needed).
9.0Following up on achieving the department schedules and plans with the team (calibration plan, Qualification plan, requalification plan…etc.).
10.0Satisfying the needs of other departments and coordinating the work with them (Quality Control, Quality Assurance, Production, Warehouse, Engineering… etc.).
11.0Supervising all validation and calibration test instruments, reference calibrators, standard weights, test materials and balances.
12.0Preparing and updating the Validation master plan (VMP).
13.0Following up and implementing the CAPA’s related to Validation and sharing investigation of deviation.
14.0Preparing and performing the media fill plan in sterile area.
15.0Performing calibration of measuring devices and balances and updating the calibration activities in SAP system.
16.0Making purchase requisition to get the quotation and work offer for new or existing equipment’s, spare parts, external validation from supplier ...etc.
17.0Supervising and training subordinates and carrying out performance evaluation for subordinates.
18.0Performing audits on external validation/ calibration service providers.
19.0Performing internal audits on validation and calibration department.
20.0Reviewing and approving the company GMP Layouts.
21.0Following up on employees’ administrative affairs such as: vacations, leaves…etc.
22.0Nominating a deputy to carry out the responsibilities of the position whenever the need arises.
23.0Preparing periodic reports with respect to the Validation function's activities and achievements to be submitted to the direct supervisor.
1.0Quality Accountability:
24.1Implementation of good manufacturing practice.
24.2Implementation of good documentation practice.
24.3Implementation of good distribution practice.
Implementation of quality systems and procedure
Educational Qualification: B.Sc. Engineer
Required experience: 7 to 10 years