Bensarif Sarapuddin

Experience

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  United Laboratories, Inc.

  Feb 2008 - Dec 2012

  Manufacturing Process Technician

  Manufacturing Process Technician, has the capability to operate machines in manufacturing area (Granulation, Compression & Coating).

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  CAD Middle East Pharmaceutical Industries LLC

  Dec 2012 - Jan 2022

  Sr. QA & RA Specialist

  • Preparation and Review of SOPs, MOAs, BMRs, Protocol and Report. • Perform Line clearance & In-process Quality assurance related activities. • Ensures that Good Documentation practice is followed at all times. • Ensures that production activity is carried out with properly calibrated/validated/Qualified equipment. • Report any deviation & discrepancy in area & activity. • Can develop an effective system for documentation and archiving of all submission. • Prepare the drug dossiers according to the CTD format and in alignment with the relevant authorities’ requirements and guidelines. • DMF filing with various regulatory authorities like SFDA, EDQM, and USFDA etc. Show less

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  AJA Pharma

  Jan 2022 - Jan 2023

  Quality Assurance Supervisor

  Quality Assurance Supervisor (IPQA & Documentation)• Supervise QA team performance to ensure GMP is enforce to meet product quality standards. • Coordinate with PPIC for Production and Packaging Plan. • Review of executed BMR, BPR, Analytical Reports and Certificate of Analysis. • Monitoring the batch release and dispatch activities. • Preparation of Annual Product Quality Review (PQR’s) • Impart the training on GMP, data integrity and other relevant SOP.• Ensure good performance of IPQA team by monitoring, training, setting expectations, providing accountability, and performing evaluations. • Follow up with implemented programs (GMP, Good Hygiene Practice, Cleaning and Sanitation, Equipment Calibration, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility. • Responsible to monitor dispensing activity. • Perform Line clearance, inspection and other In-process Quality assurance related activities.• Ensures that Good Documentation practice (Data integrity) is followed at all times. • Ensures that production and packaging activity is carried out with properly calibrated, validated and qualified equipment. • Report any deviation and discrepancy in area of responsibility. • Oversee the labeling activity, including the status, release, and destruction of rejected products. • Ensures the compliance of systems during manufacturing, packing and testing of products as per quality standards. • Ensures that sampling activity during Process Evaluation and Process Validation has been carried in accordance with the approved protocols Show less

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  AlphaPharma_KSA

  Jan 2023 - now

  Quality Assurance Supervisor

  Quality Assurance Supervisor (IPQA & Documentation)• Ensure that all policies, procedures, processes are in compliance with the cGMP, Licensor, Regulatory requirements.• Ensure that all the in-process tests are carried out as per relevant procedures.• Ensure the safety, security, issuance and control of all the technical documents of Alpha Pharma and the Licensors.• Ensure that all the finished products are dispatch according to Alpha Pharma release requirements.• Prepare the Site KPI report as assistant to QA Head.• Ensure that all factory personnel are completely trained to dispose their assigned responsibilities as per cGMP requirements.• Ensure that the annual review system of every product manufactured is regularly reviewed.• Root cause analysis management.• Revision of all technical document and quality assurance related documents.• Review of batch record for primary stability, validation batch & commercial batches.• Deviations, Change Control & CAPA Management Show less