Job Ref. ID:
QA Specialist - Quality Review Onsite
Quality Directorate - QA Operations Department
UNITED ARAB EMIRATES
UAE (RAK head office)
Quality Review - Onsite
Full Time Employment (Un-limited Contract)
The QA Specialist will adhere with the cGMP principles and perform Quality reviews as per approved SOPs.
Key responsibilities & Accountability:
Collaborates with Manufacturing, Validation and Engineering functions to drive Quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure Product Quality.
Performs a quality review on batch documentation received from manufacturing / packaging sites.
Performs a quality review of log books.
Involves in the investigations of site deviations/ Market complaints/OOS and ensuring effective root cause analysis and assigning of appropriate CAPAs.
Prepares and reviews of Annual Product Quality Review reports.
Participation in Internal and Regulatory audits.
Compliance to current Good Manufacturing Practices (cGMP) or Good Distribution Practices (GDP).
Collaborates with functional departments to resolve issues and maintain compliance.
Actively participate in continuous improvement initiatives.
Bachelor/Master degree in Science / Pharmacy
3-5 years in Pharmaceutical Industry preferably in onsite quality checks 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
Basic IT skills and knowledge in Microsoft Office (word, excel, etc.)
Document (SOPs) and investigation Reports writing in English.
Knowledgeable with Pharmaceutical cGMP Guidelines.
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