Suhas B S Email & Phone Number

Bengaluru, Karnataka, India

Leading quality management systems in compliance with ISO 13485, ISO 9001, CFR, and ISO 14971.Ensuring regulatory requirements for new product development and overseeing design quality qualifications.Approving ECNs, deviations, CAPA reports, and risk assessments.Coordinating with cross-functional teams for regulatory data collection and compliance.Ensured.

Bengaluru Area, India

• Compliance to Quality System, which includes On-line support and regulatory activities to ensure compliance to cGMP, GDP, GAMP5 and system related SOPs.
• Achieved third party certification of the quality management systems to ISO 13485:2012, Medical Device Quality System Requirements, also involved in the QMS of D&D documentation process as per current regulatory norms.
• Followed Computer System Validation CSV Master Plan to prepare, review and approve Validation deliverables for… Show more
• Followed Computer System Validation CSV Master Plan to prepare, review and approve Validation deliverables for both CSV IT and Laboratory systems as per GxP GLP, GMP, cGMP, FDA Assessment.
• Involved in Qualification activities like Facility qualification, HVAC qualification and Equipment Qualification, software validation.
• Experience, in the preparation and reviewing of validation protocol IQ, OQ, PQ & UAT.

Bengaluru Area, India

• Applied Good Manufacturing Practices (GMP) and (GDP), Training, investigations in Pharmaceutical Industry as per US and Canadianregulations.
• Executing calibration of analytical balance, HPLC (Software & hardware) dissolution.
• Experience, in the preparation and reviewing of validation protocol IQ, OQ, PQ & UAT.
• Has validated, and transferred analytical methods for software development for empower 3 assay and impurities using HPLC, UPLC, GC, UV.
• Ensuring maintenance… Show more Applied Good Manufacturing Practices (GMP) and (GDP), Training, investigations in Pharmaceutical Industry as per US and Canadianregulations.
• Ensuring maintenance of log books, calibration and laboratory data records.

Bengaluru, Karnataka, India

• Conducting analysis of in-process, finished product and stability as per standard testing procedures.
• Executing calibration of analytical balance, HPLC & dissolution.
• Ensuring maintenance of log books, calibration and laboratory data records.
• Preparing and standardizing volumetric solutions & bench reagents.
• Planning, organizing, directing, and controlling R&D activities; monitoring research activities through reporting system and advising change as… Show more Conducting analysis of in-process, finished product and.
• Planning, organizing, directing, and controlling R&D activities; monitoring research activities through reporting system and advising change as necessary.

Analysis of In-Process, Finished Product, Stability as per standard testing procedures. Calibration of Analytical balance, HPLC, Dissolution. Maintenance of Log Books, Calibration and Laboratory data records. Ensuring Preparation and Standardization of Volumetric Solutions and BenchReagents. Knowledge and experience of working in cGMP, GLP regulated.