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QA Validation Senior Specialist - Non Sterile


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

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Job Description

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The QA Validation Senior Specialist - Non Sterile will adhere with the cGMP principles and perform Qualification and Validations as per approved master plan.
Key responsibilities & Accountability:
Expert in Process Validation of Non Sterile Dosage forms (Tablets/Capsules/Liquids/Semisolids).
Expert in Cleaning Validation of Non Sterile 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.
Conducts validation activities of equipment such as Blenders, Granulators, Vessels, Dryers, Compression, Coating, Capsule Filling, Manufacturing Liquid Tanks, Filling Equipment, etc.
Conducts validation activities of Utilities such as HVAC, Water System, Compressed Air and Nitrogen gas.
Involves in product hold time activities.
Participates in Internal and Regulatory audits.
Performs all activities in compliance with safety standards and SOPs.
Temperature mapping Studies of Storage facilities.
- Education
Bachelor / Master degree in Science / Pharmacy / Engineering.
- Experience:
5-7 years in pharmaceutical industry in qualification/validation sections Non 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 and Integrity
Flexible to work in all shifts.
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 & validations.

Pharma / Biotech / Clinical Research

Quality / Testing / QA / QC / Inspector


QA Validation Senior Specialist - Non Sterile

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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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