Sanjeeb Kumar Sahu

• Ssional with over six years of hands-on experience in conducting investigations and managing quality within the pharmaceutical industry. Proficient in handling investigations related to out-of-specification, out-of-trend, market complaints, and incidents. Adept at planning, data collection, statistical analysis, root cause analysis, impact assessment, CAPA recommendation, and report writing. Strong background in Quality Management System (QMS) implementation, change control handling, audit CAPA tracking, and closure. Proven ability in handling production activities, team management, SOP preparation, training, and process improvement initiatives.

Key Responsibilities in Production Activities: Leading production activities including team handling, work allotment, and shift schedule preparations.
Contributing to the implementation of recipe-based operations in manufacturing equipment such as RMG, FBD/FBE, DCB/OGB, compression, and coating.
Providing guidance and action plans to the manufacturing floor during production events as per SOPs.
Leading investigations of non-compliant issues according to defined procedures.
Ensuring compliance with SOPs and regulatory requirements in all production processes
Job Title: Investigator and Quality Management Specialist

Summary: Highly skilled and experienced professional with over six years of hands-on experience in conducting investigations and managing quality within the pharmaceutical industry. Proficient in handling investigations related to out-of-specification, out-of-trend, market complaints, and incidents. Adept at planning, data collection, statistical analysis, root cause analysis, impact assessment, CAPA recommendation, and report writing. Strong background in Quality Management System (QMS) implementation, change control handling, audit CAPA tracking, and closure. Proven ability in handling production activities, team management, SOP preparation, training, and process improvement initiatives.

Key Responsibilities Quality Management System (QMS):

Handling and closure of change controls.
Tracking and closure of internal and regulatory audit CAPAs.
Ensuring adherence to standard operating procedures (SOPs) and facilitating their preparation, review, and approval.
Conducting training and mock trials related to Manufacturing Execution System (MES) operations.
Implementing atomization and 5S methodologies in the manufacturing process to enhance efficiency and compliance.

• Experienced operating various pharmaceutical manufacturing equipment including Fluid Bed Driers, Rapid Mixer Granulators, Blenders, Mixers, and Compression Machines from different manufacturers such as Aliance, Tapasya, Saan Engg., Sejong, Manesty, and Kilian during tenure at Cipla Pvt. Ltd.