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SUBASH SIVAN

SUBASH SIVAN

Senior Quality Assurance Specialist
Singapore

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About SUBASH SIVAN:

A versatile Quality Professional with over 15 years of experience across various industries ranging from Pharmaceuticals, Medical technology, and Semiconductor manufacturing. 

  • Extensive experience across quality assurance functions, deviations management, complaints management and batch record management.
  • Possess strong analytical approach to identify root causes and solving business challenges. 
  • Skilled at leading multicultural & high-performance teams in fast-paced manufacturing environment.
  • Strong expertise on leveraging and strategizing task execution in compliance.
  • A persuasive and collaborative communicator who can quickly build influence and trust.

Experience

Novartis | Singapore                                                                                                 2012 – Present               

Senior Quality Assurance Specialist: Jan 2019 to present 

Key responsibilities:

  • Manage all quality issues and investigation (e.g., deviations, events, OOS, CAPA follow-up, customer complaints) with the respective department and ensure that these are tracked for completion withinthe agreed timeline.
  • Review and approve all documentation related to the product, review and approve MBR and documentation associated with the product.
  • Batch disposition of excipients, activepharmaceutical ingredients, and drug product in accordance with the procedures and regulations.
  • Quality oversight in the shop floor to ensure compliance to cGMP
  • Write, update, review or approve the GMP procedures related to the department activities.
  • Review and approve SOPs, master/production batch records, change controls, BOM within MES and SAP.
  • Support the Annual Product Review/Product Quality Review for the differentdrug products.
  • Support commissioning and de-commissioning activities 

Achievements:

  • Contributed to process improvement, capacity improvement and cost reduction projects as a representative of the QualityAssurance. 
  • Involved in Digital batch review process implementation to reduce batch review process time.

Batch Record Coordinator: Jan 2017 to Dec 2018

Key responsibilities: 

  • Establish Production System (MES-Manufacturing Execution System)
  • Managing and coordinating Batch Record Reviewer administratively and task on deck.
  • Create or Review Master Batch Record for approval. 
  • Establish of GMP documentation lifecycle management. 
  • Create & Review Standard Operating Procedure & Work Instruction Production System.
  • Review Production Recipe for Process Execution.
  • Participate and support in the general manufacturing activities in audits and regulatory inspections. (WHO, HSA, FDA, KFDA, EMA and ANVISA).

Achievements:

  • Led and completed Master Batch Record harmonization project to standardize the Master Batch Record across different manufacturing units.
  • Designed and developed the MBR’s for smoother workflow and to reduce the execution errors. 

Batch Record Reviewer: Jan 2015 to Dec 2016

Key responsibilities:

  •   Review & approve completed batch record for after production for Batch release in MES Manufacturing Execution System. 
  •   Ensure Batch Record Conforms to cGMP, GMP, GDP, protocol, QRA and Dossier before approval.
  • Ensure Production System and documentation adheres to cGMP, GDP, protocol, Product Technical report, and Dossier.
  • Ensure Production Associates conforms to cGMP, GDP, protocol, PTD and Dossier.

Achievements:

  • Coordinated Manufacturing Execution System (MES) training programs from basic level to advanced level.
  • Reduced execution errors and GDP errors in batch record executions by conducting continuous training seasons for process technicians. 

Process Technician: Dec 2012 to Dec 2014

Key responsibilities:

  • Execution of Coating and Optical Inspection process.
  • Disassembly & Assembly of Parts, Equipment, and machine.
  • Liaise and support downstream and upstream associates.    
  • Handling of in-process testing and out-of-specification of granules & tablets.
  • Operate Reach Truck for material movement within process.
  • Coordinate Production Consumable usage for production.
  • Establish Production Recipe for process execution.
  • Perform Process and Product Verification and Validation test.
  • Execute Process & Machine Evaluation for Process Technicians & Operators.

Achievements:

  • Contributed towards meeting critical site KPI’s of Schedule adherence and OTIF
  • Gained rich experience of working in a fast-paced manufacturing environment, with colleagues belonging to diverse backgrounds and ethnicity.

Education

2016-2018 Advanced Diploma in Medical & Pharmaceutical Technology | Ngee Ann Polytechnic, Singapore 

2011-2012 Specialist Diploma in Biomedical Engineering | Singapore Polytechnic, Singapore.

2002-2004 Mechanical Engineering Diploma | NPA Polytechnic, India.

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