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Job Ref. ID:  20296 
Job Title: CSV Specialist
Division: Quality Directorate - QA Operations Department
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: CSV Specialist
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: Will adhere with the GxP regulations/guidelines and perform computer system validations as per approved procedure/s
Key responsibilities & Accountability: 1.Responsible for improvement and to ensure compliance of computer system validation and IT quality compliance procedure to meet the Julphar policies and procedures. 2.Preparation and review of Validation deliverables like URS, SVP, QRA, GxP assessment, FRS, DS, FRA, IQ, OQ, PQ, RTM, Data migration script and SVR etc. 3.Performs and leads computer system validation projects related to authoring and executing specifications/scripts and validation documentation for computerized processes/equipment/systems in production and laboratory areas according to the GAMP5 validation Life Cycle/USP 1058. 4.Conducts and execute validation activities for IT-GxP and Engineering computerized systems like EMS/BMS, DAS Systems and water systems, etc. 5.Write risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols. 6.Responsible for preparation, review and closure of test incidents/defects and its status reporting. 7.Perform periodic review of the GxP systems to ensure that they continue to remain validated. 8.Work with equipment owner(s) and process owner(s) to ensure the initiation and implementation of project pre-requisite like URS, change control and quality risk assessment activities etc. are in accordance with site/department procedure. 9.Handling of Computerized system related QMS like deviations, change controls and CAPA's etc. 10.Responsible to prepare and maintain the computerized system inventory for all Julphar sites/departments. 11.Responsible for management for CSV validation documents like archiving, retrieving, and distribution. 12.Preparation, review, and execution of spreadsheet validation documents.
 Qualifications: 
   - Education Bachelor/Master degree in Computer Science/Engineering Preferred Mechatronics or Electrical Engineering discipline.
   - Experience: Maximum 4-6 years in pharmaceutical industry in computer system validation sections. Minimum 2-4 years' experience in core pharmaceutical large generic manufacturing plant is preferred. Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.
   - Training:
Key Competencies: Strong written and verbal communication skills for English language. Basic IT Skills and knowledge in Microsoft office (word, excel, etc.) Honesty & Integrity Self-confident. Technical Documents (Protocols & Reports) Writing in English Flexible to work in all shifts and not sensitive to B-Lactams.  
Technical Competencies: Knowledge of regulatory guidelines relevant to Annex 11 and 21 CFR Part 11 compliance requirements, and ISPE GAMP guidelines are required. Solid understanding of Computer Systems Validation of Manufacturing, Quality and Engineering Systems. Working knowledge of regulations, such as 21 CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GEP, Good Automated Laboratory Practice (GALP) and cGMP.  
 

 
 

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