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Sr. Executive Validation

4 months ago

مصر, Egypt Jamjoom pharma Full time

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

**Responsibilities**:

- Review and Approval validation master plan.
- Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, Sops and specifications.
- Execute validation protocols when required, including preparation of, and review of, deviations associated with validation activities.
- Oversee investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required
- Ensure change controls are assessed for impact on validation.
- Preparation HVAC performance qualification protocols and reports.
- Preparation of water treatment plan performance qualification protocols and reports.
- Preparation of Compressed Gases performance qualification protocols and reports.
- Preparation of Steam Quality Protocols and reports. Validation Manager Sr. Executive Validation (Equipment Qualification)
- Preparation of BMS [Building management system] performance qualification protocols and reports. 11. Preparation of software validation protocols and reports for utilities, production equipment and lab instrument.
- Preparation of SAP validation protocols and reports.
- Preparation of IQ, OQ and PQ protocols and reports for production equipment.
- Preparation of IQ, OQ and PQ protocols and reports for lab instrument.
- Preparation and performing annual qualification plans in accordance with Validation Life Cycle SOP

**Job Specifications**:

- Bachelor’s degree of science or pharmacy
- Years of experience not less than 4 years in the same field.
- Have a professional training in GMP, GDP, GEP
- Awareness with updated regulations [WHO, FDA and EU guidelines] and guidelines [ISPE, PICs, ICH and ISO].
- Good command of English (spoken and written).
- Good Computer user or related machines required.
- Ability to analyze and interpret statistical data.