QA Senior Specialist - Sterile Dosage Forms Julphar Posted on March 23, 2020 5 - 7 years United Arab Emirates - United Arab Emirates Bachelor of Technology/Engineering, Bachelor of Science, Bachelor of Pharmacy(Pharmacy). Any Nationality Easy Apply Login To ApplyRegister & ApplyApply Without Registration Send Me Jobs Like This SEND Alert Set Successfully Opening 01 Job Description EMAIL JOB SEND Email sent successfully. SHARE JOB The QA Senior Specialist-Sterile Dosage Forms will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.Key responsibilities & Accountability:Expert in Process Validation of Parenteral and Biotech Dosage forms.Expert in Cleaning Validation of Parenteral and Biotech Dosage forms.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.Involves in product hold time activities.Temperature mapping studies of storage facilities.Performs all activities in compliance with safety standards and SOPs.Qualifications:- EducationBachelor/Master degree in Science/Pharmacy/Engineering- Experience:5-7 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. Company Industry Pharma / Biotech / Clinical Research Department/Functional Area Quality / Testing / QA / QC / Inspector Keywords QA Senior Specialist - Sterile Dosage Forms Login To ApplyRegister & ApplyApply Without Registration REPORT THIS JOB Disclaimer: Naukrigulf.com is only a platform to bring jobseekers & employers together. Applicants are advised to research the bonafides of the prospective employer independently. We do NOT endorse any requests for money payments and strictly advice against sharing personal or bank related information.We also recommend you visit Security Advice for more information. If you suspect any fraud or malpractice, email us at email@example.com People Looking for Senior QA Specialist Jobs also searched Dubai UAE All Jobs Senior QA Specialist Jobs in Dubai Quality Jobs in Dubai Pharma Jobs in Dubai Water System Jobs in Dubai Cleaning Validation Jobs in Dubai Process Validation Jobs in Dubai Verbal Communication Jobs in Dubai Senior QA Specialist Jobs in UAE Quality Jobs in UAE Pharma Jobs in UAE Water System Jobs in UAE Cleaning Validation Jobs in UAE Process Validation Jobs in UAE Verbal Communication Jobs in UAE Senior QA Specialist Jobs Quality Jobs Pharma Jobs Water System Jobs Cleaning Validation Jobs Process Validation Jobs Verbal Communication Jobs Julphar Established in 1980 in the UAE, Julphar Gulf Pharmaceutical Industries is the largest generic pharmaceutical manufacturer in the Middle East and North Africa. Beginning its journey with the first stand-alone facility that produced 5 products, Julphar now operates 15 globally certified manufacturing facilities. Distributing medicines to more than 40 countries globally, the company maintains a broad range of product portfolio that includes categories such as Pediatric Primary Care, Wound, Anemia and Women Care, Cardiopulmonary Care, Consumer Care, Adult Primary Care, Gastro Care and Pain Management. The company holds the vision to be recognized as the leader for pharmaceutical products and contribute to a better healthcare in the Middle East and Africa region. Julphar’s 13 facilities are based in the UAE while other manufacturing units are available in Bangladesh, Ethiopia and Saudi Arabia as a part of its international expansion plan. In 2012, the company also launched the only one of its kind Active Pharmaceutical Ingredient (API) manufacturing facility in the Middle East named as Julphar Diabetes, which supported its positioning among the largest manufacturers of insulin in the world. Julphar has bagged several awards and ISO9001 and ISO14001 accreditations. It works closely with regulatory bodies, such as the US Food and Drug Administration (FDA) and the UAE Ministry of Health (MOH) to ensure that all their practices are aligned with the international requirements. Julphar employs around 3,000 people around the world and believes that its corporate results are achieved due to its dedicated employees. Working for Julphar offers an opportunity for career and personal development. 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