Midhun P Das
Galway,Ireland
Summary
Hi, I’m Midhun P Das, an experienced Production Chemist with a proven track record in pharmaceutical production and quality management. Demonstrated expertise in overseeing end-to-end manufacturing processes for a diverse range of products including ophthalmic preparations, nasal preparations, contact lens cleaning solutions, herbal formulations and disinfectants. Skilled in implementing and maintaining robust Quality Management Systems (QMS) while ensuring strict adherence to Good Manufacturing Practices (GMP) and regulatory standards. Practiced in SAP HANA for comprehensive material management. Strong background in equipment qualification, validation, equipment qualification, process optimization and root cause analysis. Adept at fostering cross functional collaboration and leading teams to achieve operational excellence. Committed to continuous improvement, with a focus on enhancing product quality, operational efficiency and regulatory compliance.
Overview
2
2
years of professional experience
4049
4049
years of post-secondary education
Work History
PRODUCTION CHEMIST
Stericon Pharma Pvt Ltd
Bangalore
09.2022 - 08.2024
- Oversaw manufacturing, filling and sterilization activities of ophthalmic preparations, nasal preparations, contact lens cleaning solution, herbal formulations and disinfectants ensuring adherence to quality standards, safety regulations and production targets
- Led manufacturing operations by implementing project management methodologies to optimize workflows, meet deadlines and enhance efficiency
- Managed end-to-end qualification of production equipment and instruments, ensuring compliance with regulatory standards and continuous operational excellence
- Spearheaded documentation management including Batch Manufacturing Records (BMRs), Master Formula Records (MFRs), and Standard Operating Procedures (SOPs), maintaining accuracy, traceability and regulatory compliance
- Directed line clearance activities across manufacturing, filling, sterilization and packing operations, minimizing contamination risks while improving production flow
- Established and maintained a robust Quality Management System (QMS), ensuring strict adherence to GMP and regulatory compliance at every production phase
- Utilized SAP HANA for efficient material management, activity confirmation, raising and receiving material indents improving inventory control and resource allocation
- Led deviation investigations and material compliant resolutions through structured root cause analysis, implementing corrective and preventive actions (CAPA) to ensure compliance and continuous improvement
- Co-ordinated cross functional collaboration with Quality Control, Engineering, Quality Assurance and Regulatory Affairs teams to drive successful project execution and regulatory adherence
- Conducted risk assessments and mitigation plannings for manufacturing operations, ensuring minimal disruptions and sustained product quality
- Managed operations in an ISO 5 cleanroom environment ensuring strict compliance with contamination control protocols, environmental monitoring and aseptic processing requirements
- Executed comprehensive training programs for junior chemists, emphasizing entry and exit procedure, cleanroom protocols, GMP compliances and operational best practices
Education
MASTER OF SCIENCE - RESEARCH, BIOPHARMACEUTICAL MANUFACTURING
ATLANTIC TECHNOLOGICAL UNIVERSITY
BACHELOR OF PHARMACY -
COLLEGE OF PHARMACEUTICAL SCIENCES, GOVERNMENT MEDICAL COLLEGE KOTTYAM
Skills
- Instrument Calibration
- Process Validation
- SAP HANA
- Equipment Qualification
- Project Management
- Media Fill
- Deviation Handling
- Root Cause Analysis
Projects
Role of functional foods in health and diseases. The comparative study of regulatory requirements for the import, export and drug approval process in different countries.
Timeline
PRODUCTION CHEMIST
Stericon Pharma Pvt Ltd
09.2022 - 08.2024
MASTER OF SCIENCE - RESEARCH, BIOPHARMACEUTICAL MANUFACTURING
ATLANTIC TECHNOLOGICAL UNIVERSITY
BACHELOR OF PHARMACY -
COLLEGE OF PHARMACEUTICAL SCIENCES, GOVERNMENT MEDICAL COLLEGE KOTTYAM
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