Ishaan -*, Flat No B-**, B/H Shalby Hospital

Ramdevnagar Ahmedabad-380015, INDIA

: +91-960*******, +917*********;

: ac0z7w@r.postjobfree.com

ARUNAVA GHOSH

SUMMARY

Highly energetic, task oriented seasoned professional with over 13+ years of working experience with several multi-national pharmaceutical bio pharmaceutical companies including top 5 global pharma companies. Project management and multi-discipline engineering management experience in delivering all phases of projects

(starting from Concept Design, Basic Design, Detailed Design, Construction, Start-up, Commissioning Qualification and Validation) for leading biopharmaceutical companies and big capital projects. Over more than 10 years’ experience in delivering projects in multi-cultural environment’s in Canada, Europe, South East Asia and US.

Proven capability to deliver projects within the required schedule and budget and to the correct quality requirements.

Areas of Technical Expertise:

Process Design of Biopharmaceutical /

Pharmaceutical Facilities / Industrial Projects

System Level Impact Assessment

Computer system Validation

GAMP 5 (Automation )

Commissioning & Qualification Management

Manufacturing execution system(MES)

Certified Quality Auditor (ISO 9001)

Regulatory inspection and compliance

Quality Gap Analysis, Risk management

Validation of pharma and biopharma

Equipment’s applying ASTM 2500

Project Management large capital projects

Training & Mentoring

PROFESSIONAL EXPERIENCE

ZYDUS CADILA, Ahmedabad, India 06/2015 –Present

Cluster Head-Corporate Project Commissioning Qualification and Validation

Responsible for Managing the Commissioning, Qualification and QA QC activities for large biotech facility which consists of a Drug Product Facility, Drug Substance Facility and R&D Centre.

Responsible for directing all activities associated with the equipment commissioning, qualification/Verification, Validation (PPQ), Engineering runs and preparation for licensure at site.

Responsible for planning, staffing and organizing the Start-up team for big capital biologics facility project.

Responsible for Consulting on process issues during Concept Studies, Scheme Designs and Detailed Designs.

Ensure that all appropriate documentation such as MCCD, VDR and OMM are included in the top and handed over to the client, Track and expedite punch list items, Arrange and coordinate training for team members and Ensure that the team is adequately staffed.

Lead Commissioning Engineer overseeing all testing of manufacturing process equipment.

Responsible for coordination of processing equipment installation and services hook up.

Responsible for documentation preparation of Commissioning, Qualification and Validation (CQV) for process, equipment and clean & black utilities.

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Coordinating with Validation Team to ensure requirements met during test execution.

Interfaces with all levels of site management and client to exchange information, negotiate time tables and project implementation plans and advise on technical requirements

Assign vendors to aid with authoring and execution of engineering documents and validation protocols as needed and monitoring of their work.

Involved with the full project lifecycle implementation for Automation MES (Manufacturing Execution system) working on Pharm suite -EBMR, Emerson Syncade and PAX for plant automation and engineering.

Review of technical documentation and oversee the implementation of Installation completion inspection plan.

Responsible for Design, implementation, testing & qualification of PLC & DCS process control solutions

Responsible for performing System Level Impact Assessment and Component Level Impact Assessments Responsible for Implementing site specific validation procedures, templates and guidelines on validation activities in line with corporate policies, standards and guidelines.

Providing technical support for smooth handshake between equipment vendor and mechanical contractors.

Provides performance updates / reports views for identification of variances and corrective action.

Liaise with Senior management with regular project performance status.

Evaluate and recommend improvements to existing processes and facilities to improve all plant metrics.

Prepare Project Requirements for, select and manage Contractors as necessary to support project execution.

Support production and packaging facilities with technical leadership and facilitation of Root Cause Analysis, Focused Improvement and FMEA (Failure Modes Effects Analysis).

Develop plan for equipment FATs (Factory Acceptance Testing). Expected to lead plant personnel through FAT process from concept to production.

Participate in the development of Start Up planning with plant personnel to identify all additional labor requirements, scrap produced and start up inefficiencies.

Participate in the Capital Planning Process leveraging experience and technical expertise.

Develop project timelines and milestones around plant production commitments to ensure project completion.

Utilize Gantt charts or the like to communicate project timelines and progress.

Leverage standardization and Reliability Centered Maintenance principles to support project success.

Supervise Vendors, Contractors and Plant Personnel through project installation.

Manage development of project plans with focus on achievement of project goals.

Ensuring timely completion of deliverables

VALIDANT INC, Alexandra House, Sweepstakes ballsbridge, Dublin, Ireland 09/2014 –05/2015 Global Quality and Regulatory compliance Remediation-SME- Asia

Responsible for carefully and thoroughly identifying cGMP and containment requirements for anticancer and potent drug manufacturing facility. Lead manufacturing and technical manufacturing strategies and Quality compliance enhancements.

Provide planning for Compliance, Strategize for resolving significant compliance issues.

Perform regulatory inspection preparations and management, Conduct quality systems compliance assessments.

Provide training on compliance issues, Perform validity assessments (data integrity).

Provide scientific guidance to resolve issues related to FDA 483 observations and Warning Letters. ARUNAVA GHOSH

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Evaluate potential pharmaceutical manufacturer’s cGMP status for PQ program to identify manufacturer to be pre-qualified by regulatory audits within a reasonable time frame.

Apply international and regulatory compliance requirements and standards to GXP audits, regulatory agency responses, and remediation efforts.

Evaluate trends i.e. customer complaints, deviations, out of specification (OOS), OOT investigations, stability, CAPA, etc. to ensure systems are functioning in compliance with regulatory authority requirements.

Responsible for follow up of deviation and insist on closure using proper rationale and scientific justification.

Manage CAPA and remediation activities including regulatory responses and commitments.

Act as a lead auditor to onsite cGMP done mock inspection by overseeing the audit process from start to finish.

Provide hands-on CAPA assistance to pharmaceutical manufacturers after inspections by training on the technical matters related to the CAPA.

Reviews pre-audit information submitted by pharmaceutical ingredient manufacturers and makes recommendations on the readiness for a formal audit.

Conducts site audits of drug substance and FPP manufacturing sites as the lead auditor for a team of two.

Audit site quality operations including regulatory compliance (cGMP), training systems, laboratory operations, in-process inspections, change control, product testing, investigations, customer complaints, product disposition and validation oversight.

Responsible for review of high Quality Validation documentation.

Creates final reports summarizing the results of the site audits and makes recommendations regarding a site’s compliance with GMP.

Reports investigational and metrics findings to upper management, and, upon final resolution, provides the investigation report to the internal customer or contract customer. Initiate follow-up investigations, as deemed necessary.

BIOPHARMAX GROUP, Pune, India 01/2012 – 9/2014

Quality and Validation Manager

Completed Quality and Validation projects of Biopharmax Group clients. As a consultant worked with HBPS

(Hefei Biotech Pharma Services), Hefei,China 珐玛生物科技服务(合肥)有限公司. Life Science Park No.199 Fan Hua Road Economy and Technology Development Zone, Hefei City for four months.

As an consultant personally worked for several customers such as Scigen Biopharma, Abbott India Pvt Ltd and Dr Reddys Laboratories also indirectly worked with global international pharmaceutical companies in Israel such as TEVA, Bayer, J&J,Omrix Biopharma, Pluristem therapeutics, Datum Dental, Stem cell therapeutics and worked with Hefei Tianmai Biotech company, Hefei China for their bulk insulin API manufacturing unit at Hefei China.

Responsible for successfully executing high-profile bio pharmaceutical validation & equipment qualification projects.

Apply risk based methodology to validation efforts. As a SME support to interpret gaps and recommendations from assessment reports and write necessary protocols for indicated quality system integration, support SOP generation, process development and provide all associated training ARUNAVA GHOSH

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Responsible for review of high Quality Validation documentation provide technical expertise for preparation of specification, design documents like DQ,commissioning documents like IC,OC and Qualification documents likes IQ,OQ.

Responsible for supporting/executing various validation and process activities and adhering updated regulatory needs of FDA, EMEA, WHO and local regulatory requirements.

Responsible for assessment of suppliers by carrying out supplier audits.

Liaising directly with engineering, procurement and document control to implement QMS. Responsible for establishing and producing quality plans as management representative "MR" of organization.

Responsible for carrying out technical and behavioral training for all Biopharmax employees also involved in providing high end technical training needs by conducting seminars.

Coordinate quality assurance and quality control activities on the project site.

Responsible for implementation Company Quality Manual, project specific Quality Plan and Inspection and Test Plans.

Responsible for assisting with conducting quality audits, identifying, documenting, and providing solutions for Non-Conformances (NCR's) Corrective Actions (CAR's) & Preventive Actions (PAR's).

Responsible for monitoring Sub Contractors and ensure they are following approved specification and test plans.

Responsible for monitoring each project phases like design,construction,commisioning and validation progress and identify / rectify all (NCR's) (CAR's) & (PAR's)

Responsible for monitoring material receiving and document control activities at site.

Coordinate to top Management as “MR” with quality realization plans. SCIFORMIX CORPORATION, Pune, India 01/2011 – 12/2011 QA and RA Sr specialist

Earlier Responsibilities:

Quality and Regulatory affairs specialist in a KPO organization, Involved in authoring and interpretation of APQR (Annual product Quality Review) for Canada and US Generic Pharma clients in US and Canada.

Providing end to end solutions handling of Deviation, Change Management, Complaint Handling etc. and their interpretation in APQR and Management of projects of two US based and one Canada based Pharma clients.

Directly interacts with the technical team of clients and provides offshore support to APQR documentation.

Worked on overall Product life cycle and associated Quality documentation to prepare Annual Product reviews reports for top 5 global pharma companies.

Responsible for assisting implementation of quality systems within the Quality Assurance Unit.

Imparting training and design strategies and approaches for QA projects.

Responsible for responding to company and client requests for documentation.

Work with executive management to implement/enhance quality systems. Prepare for and assist with regulatory audits, i.e., FDA, EMEA, and Health Canada as assigned.

Project handled:

Involved in carrying out successful pilot projects at Toronto, Ontario, Canada from 4 Apr 2011 to Apr 14, 2011.

STERLING HEALTHCARE PVT LTD, Pune, India 11/2009 – 12/2010 Quality Assurance Sr Executive

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Earlier Job Responsibilities:

Lead QA group at Sterling Healthcare Pvt Ltd manufacturing Facility supporting commercial and for areas that include: raw materials testing, product testing, in-processing testing, process validation, utilities and facility validations.

Leading Quality Assurance Department and supporting manufacturing operations to achieve high quality and in compliance with cGMP.

Development & Implementation of cGMP, Review of Specifications & Standard Operating procedure of QA.

Responsible for review of QA Documents as MFR, MPR, BMR, BPR& SOP.

Responsible for review of validation protocol and reports such process validation, cleaning validation and stability Protocol and report.

Responsible for review of Annual Product Review (APR).

Ensure compliance on in process quality assurance checks during every stage of batch manufacturing.

Responsible for preparation of Site Master File (SMF), Validation Master Plan (VMP) and Quality Manual.

Responsible for review and approval of Stability and Reference sample reports. Review of investigation and reason of abnormal stability and reference samples observation

Achievements:

Lead QA team in all aspects for successful certification for TGA and EU-cGMP/EDQM audit for manufacturing plant.

AJANTA PHARMA LTD, Aurangabad, India 08/2006 – 10/2009 Senior Officer (08/2006 – 07/2009) Executive (07/2009 – 10/2009) Earlier Job Responsibilities:

Writing Quality System related SOPs; reviewing other departmental SOPs; Equipment Qualification; Water System Validation; Involved in HVAC Validation; Clean Room Validation; Batch Release; Analytical Raw Data Review; Process Validation Protocols & Reports generation; Preparation of Cleaning Validation Protocols

& Reports; Annual Product Review; Auditing & certifying the key starting materials, analytical testing labs & monitoring the vendor performance; Change Control; Deviation Control; CAPA management; Product Complaint Handling; Failure Investigation; Internal Audit; Shop Floor Auditing; Specification & STP review; Preparation of Packaging Material Specification; review of Stability study Protocol & Reports; Writing Site Master File; Writing Validation Master Plan; also worked in TB product manufacturing and smooth TT from R&D to site at Ajanta Pharma Paithan plant

Achievements:

Successfully faced regulatory inspection from US FDA, INVIMA Colombia, ANVISA Brazil, Health Canada, and WHO.

Being part of QA Audits team and successful certification of US FDA, for Paithan manufacturing plant. PANACEA BIOTECH LTD, Delhi, India 07/2004 – 07/2006 Scientific Officer

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Earlier Job Responsibilities:

Responsible for looking after vaccine batches review, follows-up and investigations on batch record and cGMP discrepancies.

Technical review and writing SOP and Work instruction

Perform daily monitoring of shop floor activity through the review of BMRs, MUCLs, Room, process, Gowning and associated documentation.

Perform Inspection and Packaging AQLs.

Conducts process and equipment validation in coordination with the technical services department.

Responsible for handling of change controls, deviations, complaints and nonconforming products in relation to IPQA.

Responsible for ensuring application of SAL work, Media Fill and other aseptic process in line with regulatory requirements.

Reviewing documents Procedures (SOP, IOP, EOP, GAM, and Specifications etc.), validation protocols.

Coordinating with FDA, helped in renewal of licenses TECHINCAL PROFICIENCY:

Automation systems (DeltaV, Siemens/Honeywell/Allen Bradley PLCs)

OSI PI Historian and operation of Pharm suite Rockwell automation MES.

Handled instrumentation and control products from Emerson, Rockwell, E+H, ABB, Forbes Marshall, Vega, Fisher, Samson, ILK, Dembla, Siemens, Yokogawa, E+E, Dwyer’s, Radix, Negele, SMC, Festo, GEMU, Mettler Toledo, Sartorius, GE, Fike, Belimo, Habonim, Nova Weigh and many more national- international brands.

Worked on projects involving DCS, PLC, SCADA from Emerson ( Delta V ), PLC/SCADA from Allen Bradley ( RS Logix 500, RS View 32, Factory Talk View, PLC 5/3, 5/4, Micrologix 1200, 1500 ), Siemens

( S5, S7 series ), Mitsubishi ( Fx series ), Elipse E3 SCADA, WinCC, Wonderware, iFix, GE Fanuc, Omran, Schneider Electric, etc.

LANGUAGE FLUENCY:

English, Hindi, Bengali, German

EDUCATION

Master of Science, Microbiology; NAGPUR UNIVERSITY, M.S; India, 2004 Bachelor of Science, Microbiology; NAGPUR UNIVERSITY, M.S; India, 2002 PROFESSIONAL TRAINING

Training attended as Quality analyst on “K2C (Key to compliance)” pharma audits on 15th JULY 2009

Training Workshop attended on “Computer System Validation and Maintenance” on 12th JULY 2009.

Training on IRCA certified ISO 9001:2008 Lead Auditor; IRCA in association with Nigel Bauer & Associates, UK and Tuv nord on March 2012, License 8358

Attended Workshop on 3rd May 2012, ISPE HYDERABAD CHAPTER - One Day Workshop - "Cross Contamination - A Risk Based Approach-Risk evaluation, Quantification, Mitigation and Management in Pharmaceutical & Bio-Pharmaceutical Industry)

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