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10 years of extensive experience in Pharmaceutical and Biotech industry as Quality Assurance Validation specialist in review/approval, develop, implement, and maintain quality assurance systems, policies and procedures to ensure compliance with FDA, cGMP, and other regulatory requirements. Experience as Lead Quality Assurance personnel for process/equipment/QC validation projects that involve review and approve validation deliverables, forms and summary reports, Standard Operating Procedures (SOP's) and User Requirement Specification (URS). Expertise in review and approve all aspects of design, validation protocols such as Validation Plans (VP), Commissioning Protocols, Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Turn Over Packages (TOP). Expertise in review and approve work orders, preventive maintenance tasks, validation documents, forms, reports (technical, environmental monitoring trend, Cleaning Monitoring Report, engineering), stability studies and risk assessments. Experience in reviewing product records for release. Participate in multiple programs in various phases of development that require QA involvement. Experience in review and approve of the equipment and laboratory unit qualification (IQ/OQ/PQ) and requalification protocols, and instrument calibrations. Expertise in review and approve vendor documents, manuals/TOP, certifications for CTUs and laboratory units. Rich experience in providing guidance and support to cross-functional teams in the development and execution of validation protocols and reports. Responsible to conduct risk assessments and process evaluations to identify areas of improvement and implement corrective and preventive actions. Involved in development processes to ensure that all changes to equipment, processes, or systems are properly evaluated and validated before implementation. Expertise in authoring, reviewing, approving Commissioning and qualification protocols, summary reports for control temperature units. Involved in pre review (quality inspection activities) of documentation in back room for FDA and EMA audits. Experience in drafting and executing Commissioning Test Plan (CTP), Installation/ Operational Qualification (IOQ), Performance Qualification (PQ) for CTUS and QC lab units such as incubators, freezers, refrigerators, freezer storage, cold storage rooms, Centrifuge, NucleoCounter, Plate Reader, Slide Warmer, Nano drop spectrophotometer, CytoFlex, Plate Reader, Plate washer and accurately recorded, compiled, and summarized results using good documentation practices. Expertise in drafting protocols for controlled EM rooms and perform surface sampling tests including static and dynamic operations. Extensive experience in performing the root cause analysis for the deviations and generated Corrective and Preventive Action plan. Collaborate with end users about deviations, issues and unexpected events that arise. Strong knowledge and working experience with cGxP (GMP, GDP, GLP, and GAMP) standards. Strong background in assessment for compliance with 21 CFR Part 11 (Electronic Records and Signatures), 21 CFR Part 211 (cGMP for Pharmaceuticals). Very good understanding of P&ID diagrams. Demonstrated critical thinking skills and ability to independently develop methods and specification. Enthusiastic, self-motivated, highly organized team player with leadership skills and possesses excellent communication skills. Skilled [Type] Specialist focused on maximizing [Description] success through effective use of [Skill], [Skill] and [Skill] abilities. Top-notch communicator with excellent time management, administrative and customer service skills. Resourceful Specialist offering expertise in problem-solving, data analysis and customer service. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions.

Awards