Hire K. R. Sathish, a pharma consultant specializing in Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: K. R. Sathish is a pharmaceutical quality assurance professional with 14 years of industry experience across manufacturing, corporate quality, and contract manufacturing oversight. His expertise includes quality assurance, GMP compliance, deviation investigations, change management, process validation, and cleaning validation. His career includes roles with Teva, Strides Pharma Sciences, Brill Pharma, and Par Formulations, supporting operations serving regulated markets. He brings practical experience in reviewing manufacturing records, validation documentation, quality trends, and quality events at contract manufacturing sites. His background also includes exposure to US FDA, MHRA, and ANVISA inspections, supporting his work in strengthening manufacturing controls and quality documentation. - Show More
Sathish supports change management through preparation, review, and approval of pharmaceutical change controls. His experience spans site quality assurance and oversight of changes proposed by contract manufacturers. He helps organizations review supporting documentation and coordinate quality assessments so that manufacturing changes receive appropriate evaluation and approval within established quality procedures.
Sathish supports cleaning validation through experience handling validation activities and collecting cleaning validation samples for quality control analysis. His background combines manufacturing QA oversight with review of validation documentation. He helps teams coordinate sampling, maintain supporting records, and check adherence to approved procedures during cleaning validation activities.
Sathish supports deviation and incident management through preparation, review, and approval of quality event documentation. His experience includes evaluating deviations, investigations, and out-of-specification events from contract manufacturing sites. He helps manufacturing and quality teams assess the information supporting investigations and maintain documented oversight of quality events affecting production and product quality.
Sathish supports GMP compliance through review of manufacturing practices, SOP adherence, and production controls. His experience includes line clearance for dispensing, granulation, compression, coating, inspection, and packing, alongside in-process checks. He also brings experience in manufacturing compliance initiatives and quality trend reviews, helping teams identify gaps and implement improvements in routine operations.
Sathish supports process validation activities through manufacturing quality oversight, review of validation reports, and assessment of process and hold-time validation protocols. His experience includes collecting process validation samples and reviewing associated batch documentation. He helps teams coordinate validation activities with manufacturing operations and maintain records that support evaluation of process consistency.
Sathish supports pharmaceutical quality assurance through experience in manufacturing operations, corporate quality, and oversight of contract manufacturing organizations. His work includes reviewing batch manufacturing and packing records, master batch records, investigations, and validation documentation. He helps teams strengthen documentation practices and maintain quality oversight across production stages and outsourced manufacturing activities.
