To Obtain a Challenging and Rewarding Position with a Market Leader That Utilizes My Skills

Raju Vyas

( + 91 9687837152 )

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Objective

To obtain a challenging and rewarding position with a market leader that utilizes my skills,

education and experience.

Summary/Profile

·  Hardworking professional offering over 18 years of experience with leading Pharmaceuticals

and Fine Chemicals Companies with demonstrated success and achievements in INDIA,USA

and KINGDOM OF SAUDI ARABIA.

·  Certified Lead Auditor from IRCA (U.K.)

·  Successfully handled more than 120 audits as per USFDA, MHRA, TGA, cGMP(WHO) & ISO-9001

·  Excellent planning, organizational and problem solving skills

·  Strong communication, interpersonal and leadership skills

·  Self starter with results-driven capacity for leadership and influence

·  Committed team player with sound judgement and outstanding analytical and time management skills

·  Ability to negotiate and liase with clients in professional manner

·  Ability to maintain a flexible and a customer-oriented approach to problem-solving.

·  Able to effectively manage time, prioritize work, multi-task across many assignments.

Relevant Experience

Comed Chemicals Ltd.(Pharmaceutical Div.) May-2011 – Present

General Manager- Quality Assurance / Quality Control

·  Comprehensive leadership and management of QA/QC & RA functions.

·  Oversee the quality assurance operations and services and ensure compliance to Current Good Manufacturing Practices(cGMP)/US FDA and other regulatory requirements.

·  Conduct product and process quality checks(IPQC) following established work instructions and sampling plans, and ensure that all products and processes meet the standards, Customer quality requirements, and regulatory requirements and regulatory requisites

·  Lead and build QA and QC Teams and provide them support -Lead international/domestic customers as well as Regulatory inspections/ audits, Complaint handing, Change control & Deviation control procedures.

·  Provide required QA/QC inputs or regulatory filings with internations regulatory agencies.

·  Responsible for all Regulatory issues with the FDA, provides regulatory guidance for staff and corporate, reviews and approves product documentation, internal audits of other facilities and supplier, insuring all manufacturing and testing specifications and it’s complied status, trains personnel & manages CAPA and non-conformance system.

·  Handling & Monitoring Validation activities (Included AMV, Process validation, Equipment validation, Facility validation, Analyst validation, HVAC validation, Water system validation)

S. D. Fine-Chem Ltd. May-2010 – May-2011

Manager- Quality Assurance

·  Management of SOPs - Create, review, approve, issue and control.

·  Managementof Deviations and Incidents - Review, approve, ensure close out of corrective and preventive actions.

·  Management of all Master Document and records - Review, approve, issue control and destroy.

·  Managing validation & Qualification activity included, Analytical Method Validation, Process Validation, Cleaning Validation.& IQ,OQ,PQ.

·  Management of Artwork - Review, approve, issue and control. Interface between the internal review team and external parties such as the printed packaging component manufacturer and the co-packer.

·  Ensure printed packaging component control at both the co-packer and the component manufacturer end.

·  Management of Change control- Review, approve and ensure implementation of the change(s).

·  Management of the Stability and reserve sample

·  Ensure completeness of the Annual Product Quality review and provide input to Regulatory, as and when required.

·  Management of IPQA activities.

·  Interface with all co-packers, distribution points and the component manufactures to properly investigate all the quality issues and ensure implementation of the Corrective and Preventive action items.

·  Perform due diligence and ensure quality compliance to the S.D Fine-Chem growing business needs

·  Researching potential inappropriate activity as identified by audits and monitoring efforts and work with Lead to escalate findings accordingly

·  Representing company for external / Inertnational audits. Conducting periodic audits of other risk areas as needed.

Montajat Pharmaceuticals (Kingdom of Saudi Arabia) March 2009-March-2010

Incharge- Quality Assurance

·  To ensure that products are manufactured in full compliance with CGMP according to the regulations in force.

·  Coordinate Training programmes, Vendor Development ,Evaluation, Vendor audits

·  To ensure that production and control operations are clearly specified in a written form and GMP requirements are observed

·  Investigation of deviations and failures, Annual product review, Trend analysis.

·  To ensure that the products are correctly processed and checked according to defined procedures.

·  Co-ordination is made for the manufacture, supply and use of the correct starting and packing materials.

·  To ensure that Self-Inspections are regularly carried out, to check the effectiveness and applicability of the quality assurance system.

·  Setting up production targets and achieve the same within time and cost parameters.

·  Analyzing the areas of improvements in processes & take adequate measures to enhance operational efficiency

·  To ensure that products are not sold or supplied before the qualified person has certified that each production batch has been produced and controlled in accordance with the requirements of marketing authorization and any other regulation relevant to the production and release of the pharmaceutical products.

·  Ensure that any type of major deviations do not occur in the premises during the manufacturing and testing of the product.

·  To ensure that satisfactory arrangements exist for the storage of the pharmaceutical products by the Company, distributed and subsequently handled, so that quality is maintained through out the shelf life.

·  To ensure that practical and effective training is imparted to all the department staff.

Optima Resources (United States of America) April- 2007 – Jan-2009

Business Analyst

·  Performs complex business analyses translating data into information. Supports business functions in the execution of business plans. Manages the process and implementation of quality data in support of all business functions. Responsible for facilitating the process of information processing and dissemination. Also responsible for developing solutions to a variety of issues of moderate scope and complexity.

·  Manages Sales Force Operations including Automation and Prescriber Universe, Reporting, Communications, information flow, and inquiry management.

·  Generation and distribution of periodic reports.

·  Ensures excellence in quality management surrounding the administration of analytical and reporting systems.

·  Supports the Business Analytics function as required by assisting and or taking the lead on data quality initiatives, operational improvement projects, and new development.

·  Prepare and develop Standard operating procedures, Operational and functional manuals to standardize work procedures

·  Schedule appointments and conduct detailed interviews with user groups and subject matter experts to obtain information about systems used within the site

·  Complete all required templates and reports ,Accurately track and report project hours.

·  Determine the appropriate retention schedules using the corporate

·  records retention database

Alembic Ltd. Feb 2007 - April 2007

Deputy Manager- Quality Assurance

Supervised activities of Quality assurance and Quality control dept.:

·  Ensured that objectives are accomplished in accordance with outlined priorities

·  Conducted and managed audits with customer

·  Carried out vendor validation, handled and resolved customer complaints and involved in product recalls study

·  Prepared and developed standard operating procedures, operation and functional manuals

·  Standardized work procedures, conducted process validation and prepared relevant documents.

·  Calibration and validation of analytical instruments.

·  Generated reports regarding market trends, monitored in-house product trends.

·  Organized training programmes for vendor audits, market trends study, calibration and SOP preparation.

·  Monitored IQ,OQ and PQ activities.

·  Support the External Quality Audit Program by working with and conducting contractor audits to assure compliance to U.S. Pharmaceutical Operations SOPs, Current and regulatory filings.

·  Support and/or lead projects as assigned such as new product launch teams.

·  Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings.

·  Author, negotiate and maintain Quality Agreements with Contractor.

·  Respond to customer complaints, including close out and determination of corrective actions.

·  Support change control efforts and ensure compliance.

·  Managed Quality systems that support compliant plant operations

·  Managed the identification, investigation, and closeout of manufacturing deviations.

·  Coordinated with Manufacturing and Packaging Directors and Managers to ensure compliance with and understanding of USFDA, Company policies and practices, and safety procedures.

·  Managed, reviewed and finalized with department supervisors the completion of inspections and audits to ensure compliance with USFDA,TGA & MHRA.

·  Prepared reports for the Director of Quality Assurance and executive management .

·  Managed department expenses; evaluates new equipment and other capital expenditures; and submits purchase recommendations.

·  Overseed, participates and approves the interviewing, hiring, and training of departmental employees; conducts performance evaluations for direct reports; and assists direct report supervisors with performance evaluation process for their units.

·  Provided support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.

·  Ensured project deadlines and performance standards are established and met as per requirement.

Comed Chemicals Ltd. ( Pharmaceutical Division ) July 2005 - Jan 2007

Deputy Manager- Quality Assurance

Responsible to look after activities of Quality assurance dept. and Quality control dept.

·  Monitored daily activities of Quality control dept. like incoming process sample, final stages samples (like tablets, capsules, dry syrups etc.) and its analysis.

·  Administered reports and released the product.

·  Conducted Internal audits, handled and resolved market complaints and product recalls.

·  Supervised calibration, validation, maintenance and troubleshooting of analytical Instruments.

·  Responsible for maintaining documents as per ISO 9001-2000 and as per WHO-GMP and make necessary changes when required.

·  Set up analysis method for new product on HPLC and GC as per the USP/BP/IP etc.

·  Keeping track of BPRs & MFCs and preparation of IQ, OQ, PQ documents.

·  Conducted orientation & training for new employees on Analytical Instruments.

·  Involved in preparing site master file, Dossiers GMP files and Validation Master Plan.

·  Participated in validation & calibration activities and administered their execution.

·  Supervised vendor validation, approved Art works and release of Batches.

·  Facilitate U.S. Pharmaceutical Operations training for areas of responsibility.

·  Represented U.S. Quality and Compliance on quality initiatives and compliance task forces as requested.

·  Maintain an up-to-date knowledge of the regulatory environment as it pertains to position responsibilities.

·  Create/Review new and existing SOPs for compliance as per company’s policies, directives and SOPs as required.

·  Review/Approve Contractor's validation protocols, Master Documents, and significant deviations and investigations.

·  Report regularly on activities to management.

·  Perform other duties as requested.

·  Manage GxP training program. Maintain training records and training database. Coordinate annual GxP training.

·  Manage corrective and preventive action (CAPA) systems including tracking of follow up activities and maintaining databases.

·  Trend quality data for presentation in Management Review meetings.

S. D. Fine-Chem Ltd. Nov 1996 - June 2005

Asst. Manager- Quality Control

·  Joined S. D. Fine Chem Ltd. as a Sr. Officer (Inst.-Q.C.) and rapidly promoted as Asst. Manager.

·  Proven experience in developing, managing and evaluating the operations of department ensuring efficient and effective deployment and use of human, financial and material resources

·  Developed, implemented and updated policies and procedures to ensure optimum quality assurance

·  Involved in protocol review and assessment with respect to workload requirements and adequacy of funding, supervision and timely distribution and activation of new protocols.

·  Demonstrated ability to handle multiple competing priorities and ability to inspire effective teamwork and motivate staff to seek solutions within a matrix system.

·  Monitored daily analysis report of raw material samples, process samples, production final samples, packing samples, R&D samples.

·  Member of Audit Team and Involved in the internal audit of analytical data, reports and laboratory processes in compliance with GLP, applicable guidelines and SOPs.

·  Implemented Windows and DOS based documentation program and designed quality procedures to meet ISO 9001 requirements, established & when necessary involved in revision of Specification, SOP etc.

·  Supervised and involved in calibration, validation, maintenance and troubleshooting of Analytical Instruments.

·  Administration of Stock availability of necessary spares and accessories.

·  Issued Certificate of Analysis.

·  Technical writer with ability to track and maintain study site data according to protocol guidelines, S.O.Ps, etc

United Phosphorus Ltd. April 1995 - Nov 1996

Chemist-QC

·  Was Involved in raw material analysis, process sample analysis (for different types of genetic pesticides), instrumental analysis (On GC, UV, AAS, Auto Titrator, Viscometer etc.), ETP water analysis, environmental monitoring analysis (for different types gases).

·  Analyzed, generated and maintained daily reports, prepared/standardized volumetric solution and working standard, maintained daily calibration on pH meter, conductivity meter, KF instrument etc.

·  Ensured adequate availability of glassware and reagents

Torrent Pharmaceuticals Ltd. April 1994 - April 1995

Technical Assistant – QC

·  Responsible for Pharmaceutical raw material analysis, soft/hard gelatin capsules analysis, tablet analysis, injection/ampoule analysis, IV fluid analysis, preparation and standardization for volumetric solution, study and analysis of drug stability, wet analysis activities like titration, TLC, viscosity, melting range, disintegration test, dissolution test, pH, conductivity, UV assay & other classical analysis as per the pharmacopoeia at Torrent Pharmaceuticals Ltd.

Cipla Ltd. Nov 1993 - April 1994

Management Trainee

·  Conducted market survey, compiled reports, preplanned product launch and promoted new products in the market.

·  Consulted, scheduled and visited doctors and pharmacists to promote relevant products

Academic Qualification

·  Certified Lead Auditor – IRCA (U.K.) Feb 2006

(For ISO 9000-2000 series QMS)

·  Diploma in Certified Quality Manager Sept 2005

(Govt. College of Engineering, Pune)

·  Diploma in Total Quality Management and ISO 9000 Feb 2002

(All India Institute of Management Studies)

·  Master of Science (Pharmaceutical Chemistry) Aug 1993

(Saurashtra University)

·  Bachelor of Science (Chemistry) June 1991

(Saurashtra University)

Other Technical Skills

·  I have been using highly sophisticated instruments like HPLC, HPTLC Gas Chromatograph, Atomic Absorption Spectrophotometer, ICP, FT-IR, UV-VIS Spectrophotometer, Digital viscometer, and Autotitrator and have thorough knowledge of the operation & trouble shooting and capabilities of these instruments.

·  Computer literate with knowledge of Windows, MS-Office, Fox, PageMaker, Coral draw, Photoshop, Acrobat reader & writer, Adobe illustrator, Internet navigation, ERP,SAP & 4S.