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Job Ref. ID:  20219 
Job Title: QA Validation Specialist - Sterile Dosage Forms
Division: Quality Directorate - QA Operations Department
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: QA Validation and Qualification - Sterile Dosage Forms
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The QA Validation Specialist will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability: Responsible for the preparation and review of validation documentation (Protocols and Reports) and SOPs to support site validation activities. Conducts validation activities for Process and cleaning. Supports and monitors Media fill simulation activities. Conducts validation activities of equipment such as Autoclave, Tunnel Sterilizer, Lyophilizer, Terminal Sterilizer, Vial washing machine, vessels CIP/SIP, filling and capping machine, etc. Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas. Involve in product hold time activities. Temperature mapping studies of storage facilities. Perform all activities in compliance with safety standards and SOPs.
 Qualifications: 
   - Education Bachelor / Master degree in Science/Pharmacy/Engineering
   - Experience: 3-5 years in pharmaceutical industry in qualification/validation sections sterile manufacturing. Real Time Experience in the companies having GMP approval from USFDA/MHRA/TGA/ANVISA/EU authorities.
   - Training:
Key Competencies: Flexible to work in all shifts and not sensitive to B-Lactams. Strong written and verbal communication skills for English language. Honesty & Integrity Self-confident.  
Technical Competencies: Basic IT skills and knowledge in Microsoft office (word, excel, etc.) Technical Documents (Protocols & Reports) writing in English. Knowledgeable with Pharmaceutical cGMP guidelines, qualifications and validations.  
 

 
 

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