SUMMARY:

• Quality Assurance leader & compliance with 8+ years in the FDA regulated industry seeks a senior position with a solid reputable organization where my skills and experience will be tapped to improve operations and processes in compliance with industry regulations.
• Comprehensive experience in Pharmaceutical/Biotech/Dietary Industry in versatile areas of Project Management; Quality Assurance; Qualifications; Facilities, Utilities and Equipment Validation.
• Well versed in writing technical documents such as Qualification protocols (URS, DQ, FAT, IQ, OQ and PQ protocols), Functional and Design specifications, SOPs, Batch records, Validation master plans (VMP), Site Master Plan (SMF), Validation reports and other Validation related documents while strictly adhering to the company guidelines and policies to ensure standardized and consistent deliverables.
• Experience as a Qualifications/Validations for Equipment and Utility Qualification (URS, FAT, IQ, OQ & PQ, Process validation, and cleaning validations.
• Experienced in driving Quality Assurance and QA auditing with excellent technical and problem solving, organizational, compliance skills.
• A thorough knowledge of industry regulations, CAPA Systems, cGMPs, incoming material and finished product laboratory processing, bulk manufacturing and packaging processes, marketed product stability program management, product trending and statistical analyses.
• Experience in quality Management systems like Change Control, Deviations, CAPA and Market complaints, Product Quality Review, Internal Audits, Product Recalls, FMEA Process and Root cause analysis.
• Assist in - process quality assurance to perform and execution of activities carried out in shop floor, personnel training and evaluation of GxP procedures.
• Extensive hands-on experience in Commissioning and Qualification (URS, FAT, IQ, OQ & PQ) of custom-built equipment such as Temperature Controlled Units including Walk-in Refrigerators, Cold Rooms and Freezers, Incubators and Validation of various process equipment including Process Vessels, Kill tanks, Blenders, Packaging, Bioreactors, Granulation Lines, Tableting machines Coating Machines Packaging lines and other systems.
• Strong background in performing internal and external audits; Represented company for several customer and vendor audits as Validation Subject Matter Expert and co-auditor; Lead Site Inspection Readiness effort at numerous occasions for Corporate Audits for Facilities, Utilities and Equipment and Quality Systems.
• Proficient in performing gap assessment of local procedures, policies, applications and operations to ensure compliance with current and updated GxP Regulations and company standards.
• Experienced coach and mentor for training and on-boarding of new hires, consultants and co-op students.
• Experienced in using Risk based approach and consistently applying Quality Risk Management for validating complex customized computerized and non-computerized systems.
• Creative and analytical with excellent problem-solving skills and troubleshooting aptitude.
• Proactive with strong leadership, interpersonal and communication skills.
• Implemented Foreign Supplier Verification Program as per FDA’S Food Safety Modernization Act.

PROFESSIONAL EXPERIENCE:

Quality Assurance & Validation Specialist

Confidential, NJ

Responsibilities:

• Performed Quality Assurance Functions related to GMP Compliance for dietary supplement ingredients and products as per regulatory Standards.
• Responsible for Qualification of new facility & Equipment’s.
• Authored, Quality Manuals & Qualification Protocols like URS, FAT, SAT, IQ/OQ/PQ of Equipment’s.
• Developed and implemented comprehensive templates for the validation protocols and summary reports.
• Executed Qualification activities like IQ/OQ/PQ of all process related equipment’s.
• Authored and reviewed cleaning validation protocols, validation master plans, technical memos, protocol addendums and assessments, for production equipment and processes.
• Authored Validation Summary Reports for executed Cleaning Validation runs and Memorandums for executed Engineering runs and taking approval of quality units to ensure GMP compliance.
• Responsible for performing and supporting visual inspections for cleaning validation of Process tanks, equipment’s, facility and utilities.
• Qualified Cold Rooms, Incubators and process vessels.
• Review of executed Cleaning Validation protocols and Engineering run protocols in GDP perspective.
• Participated in Cleaning Validation study by providing technical input in design of Cleaning Validation study protocols and execution strategy.
• Handled the Quality Management Systems.
• Authored Food safety Plan, HACCP, HARPC and Risk assessment.
• Involved in External Vendor Qualification activity.
• Involved in assisting the QA Director, Quality Assurance to perform Quality Assurance Activities such as- Authors SOPs, Issuance, Distribution, Reviewing and controlling GMP documentation.
• Performed product Quality related discrepancy investigations and supported the team for deviation investigations.
• Conducted Vendor Audits, Internal Customer Audits as required.

Senior Quality Assurance & Validation Consultant

Confidential, Lexington, MA

Responsibilities:

• Handled the Quality Management Systems like Change controls, Deviations and Ensuing the CAPA Implementation and ensuring the GMP Compliance for Biotech Products with regulatory requirements.
• Authored High Level Documents related to Validation activity, like URS, FAT, SAT, IQ/OQ/PQ of Key Process Related Equipment’s.
• Involved in Implementation and Qualification of Building Management System.
• Developed and implemented comprehensive templates for the validation protocols and summary reports.
• Authored and reviewed cleaning validation protocols, validation master plans, technical memos, protocol addendums and assessments, for production equipment and processes.
• Authored Validation Summary Reports for executed Cleaning Validation runs, Area related Qualification Activity, and Memorandums for executed Engineering runs and taking approval of quality units to ensure GMP compliance.
• Involved in visual inspections for cleaning validation of varies process related Equipment’s, Blenders, Process tanks, facility and utilities.
• Performed Temperature mapping of Cold Rooms, Incubators and Deep freezers.
• Authored and performed the Requalification Activity as required by the Schedule.

Senior Quality Assurance Specialist

Confidential

Responsibilities:

• Handled the Quality Management system(QMS)
• Expertise in Preparation of high level documents and protocols like Process Validation, cleaning validation, Masters Validation Protocols related to Facility and process related equipment and Hold time studies of Equipment’s (DEHT, CEHT & SHT).
• Performed IQ, OQ, PQ of Equipment’s like Fermenters, Process vessels, Kill tanks and Temperature mapping Study.
• Aseptic process simulation study protocol and report preparation.
• Participated in qualification of areas, instrument, equipment’s.
• Handling of Deviations and CAPAs (QMS) by classifying and approving Minor deviations.
• To perform trend on CAPA quarterly to draw a summary and conclusion to understand the weak systems to be focused, repeated failures even after implementation of CAPA identified which ensures to implement the system effectively.
• To Ensures effective root-cause analysis (RCA) is conducted during the initiation of CAPA.
• To participate in the CAPA process as a coordinator which explains to log, review, providing due dates and closure.
• Continuous monitoring of facility for cGMP compliance and following up for CAPA on the identified Non-compliances
• In-process Quality Assurance, Preparation of protocols and Equipment Validations.
• Preparation and Review of Master and Executed BMR’s, PDR’s, Tech transfer documents, SOPs and other quality related documents.
• Facility management by continuous facility visits and escalating the non-compliances with respective to facility, following the standard procedures etc. to higher management.
• Performed the Risk Assessment using ICH Q9 Tools.
• Conduction internal audits and External Vendor Audits.
• Certified internal Auditor of the company.
• Part of audit team and faced Audits like MHRA, PMDA, COFEPRIS, ANVISA.
• Prepared audit responses, reports and necessary follow-ups on the implementation of corrective and preventive actions within the identified timelines.

Senior QA Validations Specialist

Confidential

Responsibilities:

• Prepared of SOPs, Issuance, distribution, Reviewing and controlling GMP Documentation.
• Performed Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools like FTA, FMEA (ICH Q9).
• Handled all the In-process quality Assurance activities in sterile manufacturing facility. Reviewing all the GMP documents.
• Handled Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Requalification RQ of Various key equipment of production.
• Faced FDA audits, Customer Audits & Performed Risk evaluation using ICH Q9 Risk Assessment Tools.
• Authored Food safety Plan and Key member of HACCP Team.
• Part of Internal audit team and conducted External vendor audit (FAT).

Quality Assurance & Validations Specialist

Biological E, Hyderabad, India.

Biological E is the first private sector biological company in India and first pharmaceutical company in south India. Biological E supplies several essential lifesaving vaccines and pharmaceutical to UN agencies via., UNICEF.

Responsibilities:

• Performing in process checks (IPQA) at Dispensing, formulation, filling, sealing and visual inspection and ensuring that the Good manufacturing activities are followed.
• Reviewing of all the documents related to production (BMR, BPR), QC (LCR, Specifications), Engineering (Maintains schedules) as per Good documentation practices(GDP).
• Execution of validation activities like performing Re-qualifications (RQ), Preparation of protocols and also execution of the validation activities of Autoclaves, Incubators, Cold rooms, Fermenter, Deep freezers, water baths and final report preparation.
• Handling the Change controls, Deviations and ensuring the effective implementation of CAPA’S.
• Final bulk batch release.
• Successfully faced WHO Audit, CDSCO Audit for Anti Snake Venom.

Quality Assurance Associate

Confidential

Responsibilities:

• Performing Risk assessment studies for the processes and systems and preparing plans for mitigating risks with high severity by using Risk management tools like FTA, FMEA (ICH Q9).
• Performing IPQA activity followed by Dispensing, formulation, filling, sealing and visual inspection and ensuring that the Good manufacturing activities are followed.
• Reviewing all process related documents (BMR, BPR), Engineering related Maintains schedules and ensuring Good documentation practices(GDP).
• Ensuring the effective implementation of CAPA’S.

Quality Assurance Associate

Confidential

Responsibilities:

• Performing in process checks (IPQA) at Dispensing, formulation, filling, selling and visual inspection and ensuring that the Good manufacturing activities are followed.
• Reviewing of all the Batch manufacturing records and various other GMP related documents.
• Involved in CAPA Implementation and Effectiveness verification.
• Involved in daily monitoring of Temperature and Humidity of Cold rooms and also Temperature Mapping Studies.