سيد مبين

Quality Assurance Suprevisor في Dallah Pharma

• المملكة العربية السعودية - جدة
• أشغل هذه الوظيفة منذ يوليو 2013

Dallah Pharma is a Semi-solid & Liquid dosage form pharmaceutical firm based in Saudi Arabia. One of the biggest structures to produce & supply Therapeutic and Cosmetic products across the Kingdom.

-Roles and Duties:
#Validation and Qualification
•Coordinate for the preparation of Validation Master Plan.
•Preparation of Process Validation Protocol.
•Execution of process validation batches.
•Reviewing & Execution of Equipment and Utility qualification protocols.
•Execution of Hold time study, Cleaning Validation and Verification.
•Compilation, review & closing of Process Validation & Qualification (IQ/OQ/PQ) documents.

#Vendor Management:
•Vendor evaluation and qualification for raw materials and Packaging materials (Primary and Secondary).
•Make recommendations to management concerning the use of vendors based on audit reports.
•To ensure the updating of Approved supplier list in a periodic basis

#Handling of QMS:
•Change control management: Evaluation, approval and scientific disposition of changes with impact assessment from quality and regulatory perspective.
•Conducting investigations to identify the possible root cause for any deviations/Incidents/OOS from written procedures, assessing the impact of the deviation and identifying Corrective actions act and Preventive actions (CAPA) to prevent recurrence and occurrence of the deviation.

#Self Inspection
•Preparation of Annual plan for self Inspection.
•Execute inspection as per schedule covering all the departments.
•Preparation of Compliance report and follow up until the report is closed.

#Risk Management:
•Performing Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools like FMEA, Fish bone (Ishikawa) & 5 Why’s Analysis.

#Follow up the calibration plan

#Frontline exposure experience to SFDA auditing.

#Preparation of QA SOPs and review of SOPs.

#Other Jobs:
•Internal training: - Internal training to Production officers, new employees on cGMP as per schedule.
•Reviewing of Annual Productive Record.
•Revision of Batch Records, Issuance of Batch Records and final release of batches.
•IPC related jobs as Line clearance and Start up of Dispensing stage, Preparation of the batch, Filling process and Packaging stage.
•Handling of Retained Sample Room.
•Monitoring rejection policy.