Senior Quality Assurance and Compliance Officer
Alrazi Pharmaceutical Industrial Company
Total years of experience :3 years, 1 Months
• Ensure rigorous adherence to the internal quality management system and compliance with regulatory
requirements, encompassing cGMP, ISO 9001, and ISO 13485 standards.
• Evaluating the proposed changes through the Change Control process, execute suitable implementation plans,
and follow up continuously until closing.
• Evaluating the proposed Manufacturers, suppliers, vendors, and service providers and providing the required
support during the SFDA variation.
• Actively participate in internal audits, reviewing and conforming the implemented CAPAs.
• Participate in the implemented external audit, reviewing and accepting the implemented CAPA.
• Providing and driving support during the regulatory external audit and following up with relevant departments
to provide the appropriate CAPA, before the reply due date.
• Train the new employee on good manufacturing practices and good documentation practices guidelines.
• Contribute to the creation and review of standard operating procedures (SOPs).
• Ensure rigorous adherence to the internal quality management system and compliance with regulatory
requirements, encompassing cGMP, ISO 9001, and ISO 13485 standards.
• Investigating the reported incidents in the form of Deviation/Non-conformity, out-of-specification "OOS" and
Customer complaints detecting the root cause, and assigning an appropriate CAPA to prevent reoccurrence.
• Reviewing the new design Artwork and print proof and providing the approval for the purchasing.
• Attending and providing support during the internal audit and following up with the auditees till closing the
agreed CAPA successfully.
• Providing and driving support during the regulatory external audit and following up with relevant departments
to provide the appropriate CAPA, before the reply due date.
• Reviewing the finished products' batch manufacturing records and analysis results.
• conducting the annual product quality review (PQR) and monthly water trend reports.
• Contribute to the creation and review of standard operating procedures (SOPs).