Description
SUMMARY Over 7 years of diversified international experience in the Engineering sector including pharmaceuticals, oil and gas and power plants. Well-qualified to contribute in Pharmaceutical environment from Lab, Pilot Plant to FDA-compliant production. Experienced in both batch and continuous processes. Experienced in execution of validation processes, Temperature Mapping & knowledge in validation testing (IQ, OQ, PQ, RQ, CQ phase). Familiarity in Validation of RO/DI water systems. Familiarity in Cleaning Validation of equipments. Experienced in equipment Validations viz. Freezers, Ware house, cold room etc. Formulated validation protocols & executed validation protocols and prepared final reports and packages. Familiarity in all phases of Complaint Handling and Investigation - Evaluation of Complaints, Identification of products involved, Determination of Medical/Safety Reviews, Determination of Complaint Investigations, Review of complaints to determine Regulatory reporting and Complaint Investigation Conclusion and Closures. Familiar with coordinating and supervising quality incoming, in-process and final inspection activities with complete tracking. Hands on experience providing Complaint Site Investigators (Product Development, Quality Engineering, Manufacturing Quality, Technical Services etc.) with supporting information like risk management documentation, FMEA analysis as applicable. * Familiarity in Auditing, Verification & Validation, Risk Management, Lean Management, Production Management, Documentation Control and Quality Engineering in the medical device and pharmaceutical industry Developed/revised Standard Operating Procedures (SOPs), Work Instructions, BOMs, Process Flow Charts, FMEAs, Control Plans and Inspection plans criteria to outline for reference use in blueprints, drawings and specifications * Familiar/Conversant with industry codes, standards and regulations such as ISO 13485, 9001, 14001. Familiarity with FDA, EPA, OSHA and DEA. Good Understanding with 21 CFR Part 11. Knowledge in deficiency and discrepancy reports, gap analysis. * Familiarity in validation issues and designing validation test plans. Familiar with Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC). Familiarity with working with common pharmaceutical laboratory equipment - U.V. spectroscopy, IR and AA instrumentation, H.P.L.C. and G.C. instrumentation. * Mass and Energy Balances. Calculating line size, header size and flow rate. Pressure drop calculations. Proficient in Pump Hydraulics. Preparation of Conceptual design basis for the plant. * Checking and preparation of Process Flow Diagrams (PFD), Utility Line Diagrams (ULD), Piping & Instrumentation Diagrams (P&ID) & HAZOP review. Experienced in both batch and continuous processes. Familiarity in Rockwell Automation PLC/Control Logix programming and SCADA development.
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