Pharmaceutical Compliance & Validation Specialist

Mr. Hiraman. S. Jadhav

N**/SF*/**/*, Uttam Nagar, CIDCO-5, Nasik – 422009

Mobile: 988*******

Email: *********@*******.***

Pharmaceutical compliance professional with 8 years of extensive experience.

Professional Experience

Worked as a Jr Manager- IT and Systems and Compliance in Megafine Pharma P Ltd.

The Job Profile Involves:

Computer System Validation:

Experience in Pharmaceutical Industry with Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control Management testing and implementation of business applications.

Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations.

Actively participated in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams in appropriate verification and validation testing requirements.

Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.

Provide guidance/feedback to IT applications group in Validation compliance as per the applicable regulatory requirements and policies and procedures.

Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.

Create and revise Validation Standard Operating Procedures (SOPs) and other documentation to support the Quality System in regards to validation compliance.

Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices.

Work independently to determine and develop solutions that are innovative, thorough, and practical.

Regulations and Industry Standards (GAMP 5; US FDA, 21 CFR Part 11, EU Annexure 11).

Periodic trainings to the users.

Major CSV Projects during Professional work:

Involved in verification and validation activity of Chromeleone software.

Experience of handling USFDA audits independently.

All QC open systems made 21 CFR Compliant.

Compliance Management:

Taking stringent measures including preparation/maintenance of necessary document and conducting internal audits to ensure compliance with various quality standards and ensuring implementation of corrective action within stipulated time.

Evaluate and trend audit and inspection findings. Maintain audit data in a related data system.

Identify compliance risks and develop sound rational for observations against current regulatory requirement and standards. Support training sessions, audit planning and Risk Assessments.

Identify and Report Critical and Major Quality and Compliance Risks and Gaps during audit activities.

Establish effective plans, quality systems & procedures to assure compliance with all applicable regulatory bodies.

Ensure the preparedness of system/ records for external inspections/audits from regulatory agencies / certifying agencies.

Implementation of Quality Management System:

Preparation and review of Standard Operating Procedures.

Review of validation protocol and reports, checklists, qualification documents.

Development of Quality Assurance systems for compliance of regulatory audits, continuous improvement with risk assessment and management.

Monitor adherence to cGMP / Pharamacopoeial requirements;

Preparation of Validation Master Plan.

Handling of change control Procedure :

Review, assess, edit, and approve change control documentation to ensure compliance with quality, regulatory and SOP requirements.

Coach and train others on change control tools and processes and evaluate change control processes and tools to drive continuous improvement.

Monitor and communicate metrics and trend reports to management for the Change Control system.

Handling of deviation Procedure.

Review and approval of Deviation and ensure corrective action.

Preparation of Trend of Deviation.

Conducted Training Programs for 21CFR PART 11 and GAMP5.

Identify training needs of quality teams; Conduct GMP, GLP and other training programs for employees across levels and functions.

Certification:

Completed the course of “COMPUTER SYSTEM VALIDATION" from Biotrains Mumbai.

SKILL SET

Database Oracle 7.2. (12 Years)

Oracle 9i, D2K (2 Years)

Intensive programming in ORACLE (PL/SQL, Forms, SQL*PLUS*Report).

Space management of Table space data files.

Performance tuning SQL query / Database.

Knowledge of WAN/LAN connectivity.

GxP guidelines (USFDA, 21CFR Part 11 and GAMP5 Compliance)

Standard operating system (SOP) Author, review and implementation.

Computer System Validation activities assuring compliance in line with USFDA, GxP.

Incident management and change control system as per QA guidelines from compliance perspective.

Infrastructure qualification document preparation of IT.

Periodic review of computer systems which are already in line with compliance to ensure computer system validation are consistently applicable across GxP areas.

Good documentation standard practices.

Daily / Monthly / Yearly Backup setup for closed and open systems related to compliance and non-compliance.

Ensure backup data by restoring periodically up to its retention period.

Disaster management system.

Identifying compliance risks and remediation actions.

Manage Open system on network and its auto backups.

Manage internet connection as per requirement limited access.

Coaching on 21CFR Part11 and GAMP5 guidelines to respected end users.

8+ yrs of experience in pharma domain, pharma regulations & compliance (GxP, Computer System Validation)

Experience in guiding the team on pharma compliances.

Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.

Conduct or direct the internal investigation of compliance issues.

Identify compliance issues that require follow-up or investigation.

Chromeleon centralised server setup for QC analysis data.

Electronic Common Technical document (eCTD) server setup.

Network and system administration.

Previous Employer

VIP Industries Ltd., Nasik from November 1987 to December 2008.

Marsman India Ltd., Nasik from January 2009 to December 2009.

Megafine Pharma (P) Ltd., Nasik from January 2010 to December 2017.

Purchase of IT equipment

Getting indents and review as per genuine requirement.

Getting quotations from minimum 3 vendors.

Comparison of quotations for quality, prices and brand.

Negotiate and select right vendor and raise purchase order as per indent and quotation.

Release the duly approved purchase order to particular vendor.

Ensure material delivery in time as per purchase order.

Installation of received material to concerned department.

Rolls and Responsibilities.

Business continuity: Disaster management as per compliance requirements.

21CFR PART11 and GAMP5 training to GxP users.

Implementation of qualification activities for new and existing computer systems.

Ensure timely initiation and closure of all QMS document activities like defects or deviations, incident, change control and CAPAs etc.

All CSV qualification are handled as per QMS process and submit to QA for record keeping.

Support to application users to build and maintain GxP confirmed systems.

Periodical Review of compliance documents.

Up gradation of latest technologies.

Hardware Infrastructure.

AMC Finalisation.

Networking and leased lines.

Independently handling administration of IT network, Servers, security systems, hardware software, and database.

Exposure of sourcing and handling purchase of hardware, networking and software and other IT related requirements.

Working as a administrator in manufacturing company having multiple locations and offices.

Worked in SAP environment.

Exposure in investigating and diagnosing network problems and setting up user management.

Managing effective backup, security, passwords and monitoring internet and e-Mail usage.

Effective communication internaly with all departments and users.

ERP system implementation.

Effective coordination with vendors for faster delivery, maintenance and ensure maximum uptime of the system.

Travel to all locations and offices of the company as on when required basis.

EDUCATION & CREDENTIALS

Degree

University/Board

Year

Grade/ %

MBA (Software Project Management)

National Institute of Management Pune

Jun’08

A

BCom

University of Pune

Oct’87

47.67

HSC (Commerce)

Pune Board

Apr’79

61.17

SSC

Pune Board

Mar’77

53.85

Personal Details

Date of Birth : 02-Jun-1959

Contact Details : N52/SF4/23/6, Uttam Nagar, CIDCO-5,Nasik 422009 (Maharashtra)

Languages Known : English, Hindi and Marathi.

Extracurricular Activities : A keen cricket playing. Other interests

Include Swimming, Reading, light music etc.

Yours truly,

Hiraman S. Jadhav

Contact this candidate