Specialist – CSV
Job: Full Time
Ras Al Khaimah, UAE

Employer Description
Julphar is an Emirati pharmaceutical manufacturer in the Middle East. Headquartered in Ras Al Khaimah, United Arab Emirates, the company employs more than 5,000 people and distributes its pharmaceutical products internationally

Job Description
The role holder is responsible to provide support and direction to business and project teams in ‎Software Development Life Cycle (SDLC) / Computerized System Validation CSV standards and practices. Ensures ‎that all GxP computerized systems used for supporting Manufacturing, testing, facility maintenance are ‎appropriately validated and controlled as per the standards.

Responsibilities:

• Responsible for improvement and to ensure compliance of computer system validation and IT quality ‎compliance procedure to meet the Julphar policies and procedures
• Conduct and execute validation activities for IT- GxP and Engineering computerized systems like EMS/BMS, ‎DAS Systems and water systems etc
• Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance ‎guidelines. Prepare validation summary reports for executed protocols
• Responsible for preparation, review and closure of test incidents/defects and its status reporting
• Perform periodic review of the GxP systems to ensure that they continue to remain validated

Requirements:

• 4 years Bachelor Degree in Computer Science / Engineering is mandatory
• At least 5-6 years’ experience in pharmaceutical industry in computer system validation sections, out of ‎which 3 years’ experience in core pharmaceutical manufacturing plant is preferred

For more details, please scroll down & see the details.

Julphar