QMS Jr. Manager- Egypt

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.

Role Purpose:

Responsible for handling all change control requests, SAP changes, managing all deviation reports including investigation and CAPA management, performing risk assessment required for any process, handling of customer complaints, supplier qualification management, and review artwork of all packaging materials within the ALJP factory and assure compliance with the WHO cGMP, FDA& EDA regulations.

Responsible:

• Will be responsible for change control system to ensure appropriate assessment of CCRs and governance of the overall change process.
• Review and prioritize changes before assessment and approval, follow up actions and monitor site change control performance on periodic basis.
• Responsible for deviation handling system including, investigations and CAPA Management process to ensure its effective closure in timely manner in addition to its effectiveness.
• Lead risk management process in all facility areas & set appropriate mitigation actions.
• Participate in internal audit process.
• Handle customer complaint system including, investigations and CAPA Management process to ensure its effective closure in timely manner in addition to its effectiveness.
• SAP changes (recipe, BOM, codes) review & approval.

Qualifications :

• University graduate pharmacy, or science.
• 8-10 years of relevant experience in sterile manufacturing in the pharmaceutical industry.
• No less than 2 years in a similar position.
• Up to date knowledge of current GMP, EDA Regulatory requirements, WHO & ICH guidelines.
• Working knowledge in FDA, WHO and ICH guidelines.
• Excellent investigation and report writing skills.