Job Ref. ID:
QA Validation Senior Specialist - Non Sterile
Quality Directorate - QA Operations Department
UNITED ARAB EMIRATES
UAE (RAK head office)
QA Validation and Qualification
Full Time Employment (Un-limited Contract)
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.
Bachelor / Master degree in Science / Pharmacy / Engineering.
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.
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.
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.
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