Satish Pasala Email & Phone Number

Over several years experience in Medical Device, Standard Operating Procedure SOP, Quality Management and Good Laboratory Practice GLP. Strong knowledge and expertise in Medical device product development (QMS) process implementation, Quality Systems management, quality audit and corrective action plans. Good understanding of FDA guidance on Quality Assurance/ICH GCP requirements for medical device industry and compliance. Very strong skills in problem solving, analytical thinking ability and communication with all levels of people to support the company goals. Always open to new challenges in the Pharmaceutical or Automotive industry

Listed skills include Regulatory Affairs, Quality Assurance, Capa, Glp, and 1 others.

• Junior Research Assistant

  Suven Life Sciences Limited

  Nov 2012 - Present

   Plan and conduct internal audits, study audits and routine process audits for pre-clinical studies as per GLP requirements. Ensure corrective and preventive actions timely  Writing and review of quality system procedures (QSPs) and Standard Operating Procedures (SOPs) Proactively focus on Quality system improvements. Review study/project protocols/plans, data and Reports To carry our auditing of live phase Training staffs on GLP requirements Manage all QA activities pertaining to the departments involved. Control and issue of forms, logbooks, SOPs and documents. Maintaining CVs and Training files with updating. Ensuring equipments calibration status at prescribed time period Instant communication of observations and regular follow-up for the response. Archives maintenance and procedures  Internal auditor: review of LC-MS and instrument calibration reports, employee training files Multiple activity live-phase auditor: reviewing of dose and formulation calculations for multiple types of studies Review and approval of study protocols, raw data and reports for studies like pharmacokinetics, receptor occupancy, brain microdialysis, in vitro metabolism

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  Sri Sarada Vidyanikethan

  Ssc