Risk Assessment 3Rd Party

Vishwash Joshi * P a g e

Vishwash Joshi

ad5mzp@r.postjobfree.com M – +1-267-***-****

MICROBIOLOGY & QUALITY PROFESSIONAL

Quality Risk Assessment & Compliance ~ Process Optimization and Validation ~ Investigation & CAPA~ Data Integrity / Reliability ~ Method Validation ~ Aseptic Handling, Behavior, Practices ~ Sterilization ~ De-pyrogenation ~ Remediation & Monitoring Plan ~ Customer Centric

Designing to Inception and Qualification to Commercialization as Green Field project.

Consultation review for project related & statutory documents given to agency & stakeholder in time.

Providing technical inputs for establishment of manufacturing, packaging and warehousing facility in compliance to core regulations and guidelines.

Operational proficiency on Aseptic Processing (Vial, Ampoule, Pre-filled Syringe)

Providing technical assistance for inception of Microbiology Laboratory for regulated markets.

Proficient in review of Utility System (HVAC, Water, Compressed Gases) Qualifications & Validation as per ISO / ISPE.

Project task review within team and regular updation on Technical Guidance’s.

Proficient in driving business efficiencies for 3rd party pharmaceutical manufacturing.

Accomplished multiple cGMP System Assessment & Certification Project, System Remediation & Compliance Verification Projects for Multi-national Companies into Regulated Market. (US-FDA)

Engaged and accomplished 3rd party Batch Review & System Assessment / Certification / GAP Assessment projects for both API and Formulations manufacturing unit.

Hands on as quality professional for Bio-pharmaceutical manufacturing & testing e.g., Wosulin Dispo-pen (recombinant Insulin), Wepox (erythropoietin).

Development / Writing of technical documents (SOP / Protocol), Imparting Technical Trainings (E.g.) Aseptic practices & Behavior into classified clean rooms, Investigation & CAPA, Data Reliability & Integrity

Building Professional Team by people interaction, hand-holding on technical investigations, management of QMS with effective turn around time, FUNCTIONAL COMPETENCIES

Operational Excellence Lean Lab-management, Optimization of sampling & testing plans, Establishing Environmental Monitoring Performance Qualification (EMPQ), Implementing Risk Based Environment Monitoring Plans for CLEAN ROOMS,

Qualification for Technology shifts Bacterial Endotoxin Testing (BET) from Gel-Clot to Kinetic / Turbidimetric Methods, Shift from Open Funnel Filtration Method to Closed System Methods for STERILITY TESTINGS,

A Core Quality Professional with solid hands-on experience in microbiology, spanning two Decades into Aseptic Processing & Testing environments. Expertise in QA, Pharmaceutical Microbiology, profoundly engaged into technical concepts of behavior into Clean Rooms, Sterilization, Sterility Assurance, management of compliance risk assessment, optimizing test methods across global manufacturing network, process remediation, operational growth drivers, team building, technical trainings, efficiency, decreasing down time and cost reduction. Global Exposure: U.S, U.K, E.U, Australia, APAC and India Industry Expertise: Injectables - Aseptic Powder Processing, Terminal Sterilization, Pre-filled syringes (PFS) Oral Sold Dosage Formulations (OSD) Active Pharmaceutical Ingredients (API)

Vishwash Joshi 2 P a g e

Handling and Enumeration of Biological Indicators, Load Pattern designing and Stem Sterilization Process Validation, De-pyrogenation Tunnel and Chamber Validations,

Air Flow Visualization Studies (SMOKE STUDY), Technical Trainings on Behavior & Aseptic Practices into CLEAN ROOMS,

Conducting Process Simulation Trial Runs for Aseptic Powder Processing, Terminal Sterilization, Pre- filled syringes, Bio-similar Analogs (MEDIA FILL RUNS),

Facility Qualifications (HVAC), Area Cleaning & Sanitization, Sanitizer Efficacy Challenge Studies, Microbial Sub-culturing (Seed-Lot Technique) and Storage, Microbial Identifications, (VITEK 2, 16s rRNA) Upstream and Downstream Process Controls as Aseptic Compounding, Sterile Filtrations, Homogenization, Aseptic Product Filling (Isolator Technology).

Managing Quality operations (Aseptic Powder Processing, Terminal Sterilization, Pre-filled Syringes, Oral Solid Dosage Forms) and compliance plans (Aseptic Powder Processing, Terminal Sterilization, Oral Solid Dosage Forms, API), Product Process Validations, Laboratory execution and compliance, Sample Management and Processing on shopfloor, People Hand-Holding on techniques.

Managing regulatory remediation operations (WL and 483 observations) and Integration activities.

Technical Review and Compliance Building Write-Review of Procedure (SOP / Protocols), Process, Practices & Systems, on-site gap assessment and hand holding for people practices & Operational management on manufacturing shopfloor.

Change management (building strong quality culture and high performing cross functional teams)

Managing third-party (Investigators / SMEs / Auditors / Customers / Trainers / QP)

Primarily focused on integration of microbiology laboratory, validation and qualification approach with global standards to ensure business continuity and growth. Also participated in development of robust microbiological testing methods and its submission to agency. Training of personnel/s working in clean room on aseptic practices & behavior. Investigations and CAPA with Technical Writing.

Put in order all 3-microbiology testing laboratory and clean room sampling and monitoring strategies up to required standards to support inspection readiness, hosting audits, and establishing compliance with risk-based mitigation.

Conducting process validations, Hold Time Studies and Cleaning Validation / Verifications. PROFESSIONAL EXPERIENCE

Technical GMP Consultant – GxP

Technical Consultant on Quality and Compliance, result – oriented professional by managing multi – disciplinary team on project. Proficient at identifying deficiencies and integrating systematic solutions to establish compliance and achieve organizational strategy.

Management:

Contributed in providing leadership and strategic direction on testing optimization, establishing reduced sampling and monitoring plans, team building and integration projects, Audit compliance.

Represented the firm & participated in multiple regulatory audits and provided CAPA & compliance. Administered culture of “Ethics and Compliance” to align with company’s mission.

Technical:

Quality System Gap Assessment for process, procedures, people competency & imparting technical trainings Process Implementations & controls into Network systems for multinationals.

Technical Review for generated retrospective QMS elements identifying area of improvement

Providing technical assistance on to compliance establishment and writing response updates to FDA-483 observations and Warning Letter observations.

Lead on handling compliance & remediation efforts for pharmaceutical facility (API & Formulations)

Investigational assessment, report writing on Quality Metrices Trend outcomes, evaluation of failure modes in Microbiology, Facility, Production & Material systems, eradication of errors.

Documented success in developing policies & procedures, and implementation of process mapping & Risk Assessments, Change Control, Deviation Management, CAPA, Complaints, Qualification & Validations, Review and compliance to Data Reliability / Integrity, document management, Improving QC process to ensure compliance with specialized project initiatives.

Vishwash Joshi 3 P a g e

Facilitated quality system improvement by site-based project and initiative overseeing, Dissemination of best quality culture practices across section/s under quality management system to ensure implementation of compliance commitments and to achieve organizational goal.

Support to site quality on handling and management of Remediation process and Tracking.

QMS – Handling of Quality documents like Change Management (CCP / Deviation), Out of Specification (OOS) / OOT / OOC / Laboratory Incident / Quality Trend Preparation and Analysis.

Quality Risk Assessment and Investigations for Product / Process / Facility / Equipment using Quality Tools 80:20, Ishikawa [Fish Bone], FTA, 5 why analysis, FMEA, FTA, Brainstorming.

Vendor Management – Actively involved in Vendor Audits and Qualification / Approval process.

Continuous Improvement Plan with use of Self – Assessment / Internal Audit Program

Training – Approved trainer on cGMP / GDP / 21 CFR – P-11 / Data Integrity / Investigation & CAPA

/ software validation and qualification for Application & CDS networks / Operational Aseptic Manipulations, Practices & Behaviour, Environment Monitoring, Sterilization concepts.

Electronic Systems/Controls Proficient assessment Qualification / Validation dockets for Document Management System [eDMS], Training Management System [eTMS], Trackwise (T/w) Work flow

Equipment Qualification / Validation expertise over review on URS, FAT, SAT, DQ, IQ, OQ, PQ, Mapping. Process Simulation Trial’s (Media Fill) – execution expertise into designing & review EXPOSURE OF REGULATURY INSPECTION

USFDA (10), MHRA (08), TGA (02), ANVISA – Brazil (03), GCC (04), WHO - Geneva (04), MPA – Sweden (1) and for INERNATIONAL/ NATIONAL CUSTOMERS & AUDIT BY QP (EUROPE) ORGANIZATIONAL EXPERIENCE

Have overall about 22+ years of experience in field of Pharmaceutical Manufacturing, Packaging, Storage and Quality Assuracnce (QA / QC) and Microbiology: Have worked with Leading Multi-national Pharmaceutical Companies like:

Work Exposure with Consulting Firms Prologic Inc. and BEC-USA since last 4.5+ years. Have exposure on Compliance, Assessment, Remediation and Audit roles as Quality Consultant for multinational companies in India, Malaysia and USA. Completed Last Project at Pennsylvania (PA) – USA.

PENN LIFE SCIENCES LLC, (PA) – USA. (Current Employer – Working on H1B Visa since Nov 2022)

BAXTER INDIA Pvt. Ltd. Ahmedabad & Chicago (previously known as Claris Injectable Ltd.)

UNIMARK REMEDIES LIMITED - Ahmedabad.

PIRAMAL ENTERPRISES LIMITED – Mumbai / Ahmedabad

IPCA LIMITED – Mumbai

ALKEM LIMITED - Daman

WOCKHARDT LIMITED – Waluj, Aurangabad

LUPIN LIMITED – Ankleshwar / Bhopal

EDUCATION

Bachelor of Science (Microbiology) South Gujarat University, India

Master of Science (Biosciences) South Gujarat University, India

Diploma in Medical Technology BSMT, Mumbai, India TECHNICAL TRAINING:

Sterility Assurance - A Residency Training – Chicago, USA

Principles of Effective Human Error Investigation, Manual Pena, Puerto Rico, USA

Good Data Management Expectations from U.S. FDA, Dr Pepe Rodrigues, USA

Investigation / CAPA System & Human Errors Reduction Certification, Dr Pepe Rodrigues, USA

Effective Compliance Writing for Personnel Involved in Investigations, Manual Pena, USA

Measuring Training Systems Effectiveness - Building a Chain of Evidence, Dr Pepe Rodrigues, USA

ACCREDITATIONS:

Certified Trainer

Certified Auditor

Contact this candidate