Job Details
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Job Description
Your Responsibilities:
Job Purpose
- Represent the validation activities within the Validation Working Parties and generate the required validation documentation and execute/witness validation activities
Key Accountabilities/Responsibilities
- Participate in different validation working parties for organizing the different validation activities for process equipment and utilities upgrades.
- Ensure that all validation activities and documentation are complying with the mandated QMS requirements under direct supervision of Validation Section Head.
- Prepare Design Review (DR), installation/operational qualification (IQ/OQ), performance qualifications (PQ), protocols and validation reports (VR) for different validation activities for process equipment and utilities upgrade in accordance to VLC and CSV equipment.
- Participate in execution of qualification testing with different departments.
- Follow up, with different departments and external suppliers, completion and review of the required qualification testing documents.
- Support the implementation of company safety rules.
- Report validation KPI’s to Section Head. Prepare validation review protocols, conduct review activities and prepare validation review reports for process equipment and utilities.
- Prepare decommissioning protocols, conduct and coordinate related activities and prepare decommissioning reports for process equipment and utilities.
- Attend change control panels relevant to process equipment and utilities upgrades and de-commissioning.
- Participate in preparation of risk assessments for process equipment and utilities.
- Support GPS implementation for managing Validation different activities.
- Responsible for performing validation maintenance / review through preparing protocols, collecting evidences and reporting to section head.
Job Requirements
Why You?
Basic qualifications:
- Bachelor degree of Engineering
- Minimum 2 years experience in a similar position, preferably in pharmaceutical company.
- Good background of Pharmaceutical manufacturing requirements.
- Good background of GLP, GMP and GEP requirements.
- Good experience of Calibration.
- Good knowledge in HVAC, control and Sensors technologies.
- Good command of English language and Computer skills.
- Good communication and organization skills.
- Good computer skills.