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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