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.

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.

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.