Validation Engineer

About MS Pharma:

MS Pharma is a leading pharmaceutical company specializing in the development, manufacturing, and distribution of generic and biosimilar medicines. Founded in 1989, with headquarters in Amman, Jordan and a Corporate Management Office in Zug, Switzerland, MS Pharma operates across 12 countries with more than 2,000 employees serving patients throughout the Middle East, North Africa, and selected European markets.

Description:

Carry out the required validation tests and perform installation and operational protocol duties, analyze the results of testing and determine the acceptability of results against predetermined criteria in a timely manner and in compliance with cGMP and SOPs and manufacturing instructions.

Responsibilities:

• Prepare the Validation Master Plan (VMP).

• Prepare and execute qualification (IQ, OQ, PQ) and requalification protocols for production machines and analytical instruments in coordination with Production, Quality Control, and R&D.

• Conduct validation studies following related SOPs, protocols, and policies.

• Prepare SOPs related to validation activities.

• Follow up on the execution of validation plans and make the required arrangements for that.

• Conduct temperature and relative humidity mapping studies for warehouses and stability chambers and prepare protocols for validating the method of storage in warehouses and stability chambers.

• Prepare and execute utilities qualification protocols, manufacturing process validation protocols, cleaning validation protocols, and software and computerized systems validation protocols.

• Check and follow up on air and water quality validation.

• Ensure that all validation tools and instruments are kept clean and in good condition.

• Follow up on the calibration of validation instruments in order to execute all validation tasks using properly calibrated equipment.

• Report to the Manager of Validation any deviations from SOPs, protocols, or policies.

• Coordinate with other departments or outside contractors/vendors to complete validation tasks.

• Coordinate with external entities responsible for analytical devices marketing to conduct qualification studies for new devices.

• Adhere to the current good manufacturing practices in all activities.

Qualifications:

BSc in Chemical engineering, Mechatronics engineering or any related field as per the country regulations

0-2 years experience in a related field.

Good written, read and spoken Arabic and English.

Required Experiences:

• Knowledge in (ISO 14001) system

• Ministry of Health Regulations

• Ministry of Environment’s Regulations

• Knowledge in ISO 14001, I14644-1, -2, -3, & -4

• FDA Regulations

• Knowledge in the systems such as ICH, GMP, GLP, WHO

• Process, design, installation, operation, manufacturing machines, utilities

Our Culture:

• At MS Pharma, we are guided by our Triple T values:
• Take Charge – Lead with accountability and courage
• Together for Better – Collaborate with trust and respect
• Thrive – Drive innovation, growth, and continuous improvement

Job Location: Amman, Sahab