CURRICULUM VITAE

DARSHANA SHAH Cell: +91-9833016164, +971525316024

+91-9320970480 E-mail: darshanagohil@gmail.com

Passport No.: K9274210 Visa: I can avail dependent Visa Experience at a glance:

1. IDA Foundation (Mumbai,

India)

Oct 2005 till date

2. Ajanta Pharma (Mumbai)

Dec 2004 till Oct 2005

3. Associated Capsules Ltd

(Mumbai)

Dec 1996 till Dec 2004

Strengths:

¾ Leadership and team

performance attributes �

¾ High Conceptual skills�

¾ Respects deadlines��

¾ Effective communication skills,

both written and verbal �

¾ Presentation Skills

¾ Good interpersonal skills �

¾ Problem Solving skills

¾ Innovative and Creative�

¾ Capacity to learn�

�

Functional Summary: A Quality Assurance and Regulatory affairs professional having around 19 years of experience in Indian and Multinational Companies in varied fields like Global Regulatory Affairs, Quality Assurance, Quality Control and Compliance, with a proven track record of efficient team management and deliverables. Expertise in GMP audits as per WHO guidelines. Experienced in Regulatory requirements of health authorities of Rest of the World (ROW - all other non-regulated). Well versed with WHO GMP, ICH , EMEA Guidelines and ISO 9001 & ISO 13485 requirements. Career Objective: With intent for a lateral uplift, utilizing my abilities and experience, clubbed with skills and virtues like communication, compassion, integrity, intelligence and organizational, analytical & managerial capability, would like to take up a suitable and challenging role in your esteemed organization. Work Experience:

1) IDA Foundation (Mumbai, India) Head Quality & Regulatory Affairs from Jan 2015 till date Manager Quality & Regulatory Affairs from Dec 2007 till Dec 2014 Unit Manager – Registrations from Oct 2005 till Nov 2007

Job Responsibility: x Part of Management Team in IDA Foundation India office since Dec 2007. x Responsible for overall functioning of Quality and Regulatory Affairs department in

India office and leading a team of 14 to18 personnel. x Functionally reporting to Quality Affairs Director in Amsterdam and Administrative

reporting to General Manager IDA-India. x Resource Management for Regulatory affairs, Quality Control and Quality Assurance

IDA India. x Responsible for annual departmental budget & review and revise forecast on bi-

annual basis. x Abreast Management (India and Amsterdam) on departmental activities through

Monthly reports, Balance Score Card and Annual Report. x Bring awareness to staff and suppliers/customers/stakeholders when necessary on

IDA Quality system. x Responsible for compliance in operational practices in India office. Functional Responsibilities:

A) Regulatory Affairs x Ensure that there are no stock out situations due to regulatory activities x To provide regulatory expertise to all involved functions – locally and globally x Life cycle management of marketing authorizations of products (responsible for

variation submissions, renewal applications, annual reports) x To finalize the strategy for variations x Training to group members – regulatory related / systems related. x To support all local and global initiatives

Educational (Professional) Qualifications: x Master of Science in Microbiology,

1996, Mumbai University, India

x Bachelor of Science in Microbiology,

1994, Mumbai University, India

Received Scholarship from Mumbai

University in the year 1995 (for

being one of the top 16 in Bachelor

of Science in Mumbai University)

x Pursuing PGD in Management from NMIMS Global Access

Certifications:

¾ Registered Microbiologist with FDA Maharashtra

¾ Internal Auditor for ISO 9001 standards

Computer Skills:

¾ All Microsoft office programs, including Excel, PowerPoint and word �

�¾ Conversant with ERP (Navision,

JD Edwards)� Languages Known:

¾�English ¾ Hindi�¾ Marathi�¾ Gujarati�¾ French �

�

x To check on all activities as per the defined procedures / as per defined systems. x Assessment of the documents required for preparation and compilation of

variation package / dossier. x Review of marketing authorization applications wherever required. x Review of annual reports / variation / renewal applications wherever required. x Review of documents required for submission of response to the deficiency

letters wherever required x To support tender related activities (kick-off meetings, Fiche Techniques) x To keep ready updated status of all projects. x Responsible for strategic decisions with respect to Registration policy for the

entire organization.

B) Quality Assurance x Part of the strategic team to design and review Quality Policies.

- Have prepared policy on Sterilization requirements, Batch verification audits, sampling and analysis of samples, Risk analysis, retention samples.

x Involved in strategic sourcing (manufacturing sites and products) along with procurement function.

x Responsible for planning and execution of GxP audits for qualification of manufacturers (pharmaceuticals and medical devices) in India as per WHO/EMEA guidelines. - Have experience in conducting about 40 GxP audits in India and China for

Sterile preparations (LVP & SVP in glass and PE (FFS)), sterile powder for injection, Oral solid dosage forms(cephalosporins, beta-lactam and non beta-lactam), liquids and powder for suspensions, sterile and non-sterile ointments, soft gelatin capsules & disinfectants, Outsourced Laboratories for analytical services, Outsourced CRO for Bioequivalence studies, transit warehouses. Also in Medical devices (Blood bags, IV placement units, Resuscitators.

- Conduct Investigation audits when necessary as a part of CAPA for any major/critical customer complaints.

- Have led audits with co-auditors from MSF (Holland & France), Have experience of being a co-auditor for 2 sterile facilities in India with Mr. Patrick Hoet, an Internationally Qualified auditor for WHO/MSF/UNICEF.

x Responsible for planning and execution of data/ batch verification audits. x Support compliance to EuGDP by liaising with Supply Chain, Suppliers & QA

Amsterdam for Direct Shipments (shipments & transit warehouses). x Assure capacity and support for approval of products (pharma, non-pharma and

diagnostics for Pooled Procurement Mechanism (Global Fund program)). x Assure execution of Bioequivalence Studies as per IDA policy and planning. x Quality Management

- Ensure India office operates in compliance with ISO 9001 guidelines. - Support and propose improvements in getting 90% of procedures in place. - Assure that procedures are adapted to new ERP system for Quality Affairs

India processes. - Monitoring Quality system including Internal ISO audits and Compliance

Audits in India office. x Perform Quarterly Review meetings with Suppliers. x To support external audits (Customers like Save the children, Clinton

HIV/AIDS initiative, Stake Holders like Global Fund) x Coordinate with suppliers for any Deviations and Customer Complaints.

Overseas work experience: ¾ Attended business meetings /

workshops in Europe – specifically in

the Netherlands during the period

2007 to 2015.

¾ Business trip to China in 2009,

Bangkok – 2012.

¾ Business trip to Srilanka in Feb 2016.

Participation in global activities: �¾ Represented IDA Foundation in

WHO’s Regional SEARO meeting

on Rational use of medicines in April

2012 at Bangkok.

¾ Represented IDA Foundation in

WHO’s Regional SEARO meeting

on Strengthening Quantification and

Procurement of Essential Medicines

in June 2014, at WHO’s office at

New Delhi.

Seminar / Presentations/Workshops / Training Program conducted: ¾ Introduction to QA and basic

Navision to Tender desk

¾ Registration Workshop - Sales &

Marketing

¾ Seminar on Sterility testing – QA

India and QA Amsterdam.

¾ Participated in Suppliers summit

in 2012 & 2015 conducted by

IDA India. Presented IDA QA

Systems and QA India activities

to various customers and stake-

holders as well as IDA

Foundation Board members in

the capacity of Manager/Head

Quality & Regulatory Affairs –

India.

C) Quality Control x Development of external laboratories and ensure that the inspection and analysis

is performed as per standard analytical method and inspection procedure. x Active involvement in finalization of periodic Technical service agreement

including costing. x Assure timely planning and execution of inspection and analysis x Assure timely delivery of analytical services from external laboratories. x Assure timely release of batches for Direct Shipment and ensure compliance of

the batches as per IDA specifications before release. x Timely execution of entire quality control part in the supply chain for wholesale

orders, tenders and large programs (CHAI, GDF, PPM core & non-core) x Ensure performance of Risk Assessment and trend analysis on defined

frequency. x Conduct Performance review meetings with laboratories in India, China and

Singapore on quarterly basis and propose improvements.

Work Experience: 2) Ajanta Pharma Limited, India Assistant Manager – Regulatory Dec 2004 till Oct 2005

Functional Responsibilities: x Leading a team of 14 personnel. x Planning dossier submission in coordination with sales & Marketing team for

South East Asia, Latin America, East Africa & Central African countries. x Review of documents required for submission of registration, liasing with

manufacturing unit for legal documents (COPP, FSC, GMP, Manufacturing licence)

x Liase with Analytical development department for product specifications and stability data.

x Ensure timely submission of dossiers and coordination with regulatory authorities/agents for Marketing authorizations.

x Preparation and review of documents required for submission of variation application to various Drug Regulatory Authorities.

x Preparation and review of documents required for submission of response to the deficiency letter sent by the Regulatory authorities.

x Preparation of Site Master File (Chikalthana & Paithan manufacturing units) as per PIC/S guidelines.

x Participation and preparing the manufacturing unit for UNICEF, MSF audit. x Preparation of tender documents for UNICEF, MSF, Global Fund Anti TB and

Anti Malaria program. Preparation of Fiche de Techniques for Francophone countries.

x Ensure systematic electronic back-up of submitted dossiers. x Conduct internal audits of Formulation Development and Analytical

Development departments, Conduct GMP audit of manufacturing unit at Paithan and Chikalthana.

x Responsible for ISO documentation and SOPs for manufacturing units and R&D

Seminar / Workshops / Training Program attended: ¾ 2007 - Internal Auditors training(ISO

9001 standards) by Bureau Veritas

¾ 2009 - Validation of Compendial

Procedures by USP.

¾ 2010 - Conducting and facing GMP

audits effectively.

¾ 2010 – Presentation Skills

¾ 2011 - CTD and eCTD submissions

¾ 2011 - Workshop on Corporate

Finesse & Etiquette.(Sabira

Merchant)

¾ 2013 – Bioequivalence Studies

¾ 2014 - Sterile Pharma Workshop

¾ 2014 - Project Management

Workshop

¾ 2014 – Advanced Excel training

¾ 2015 - Awareness training on ISO

9001:2015

¾ 2015 - Attended training programme

on ERP software JD Edwards –

Wholesaler’s module

Personal Details: DOB : 15th June 1974 Gender : Female Nationality : Indian Marital Status : Married Hobbies:

¾ Cooking �¾ Stitching/Embroidery�¾ Traveling

References : On request

Work Experience:.

3) Associated Capsule Ltd, India – ACG Group Microbiologist – Quality Assurance Dec1996 to June 1999

Senior Microbiologist – July 1999 till Feb 2003 Officer QA – Mar 2003 till Dec 2004 Functional Responsibilities:

x Responsible for Sampling and Microbial analysis and release of Starting

Material, In-process and Finished Product. x Responsible for sampling, analysis and release of Packaging Material. x Support development of Preservative Free Capsules. x Ensure calibration and validation of autoclave, incubators, oven and LAF as per

defined frequency and keep records. x Coordinate with functional heads for departmental targets(stretch goals) on

monthly basis as a part of quality objectives for ISO compliance. Highlight the out of trends if any through monthly reports.

x Conduct audit of the manufacturing unit at Kandivli, Shirwal & Dahanu. x Update the DMF, as per the changes in the dossier submitted to USFDA bi-

annually. x Responsible for providing questionnaires as required by customers for vendor

approval. x Conduct analysis/joint analysis and resolve customer complaints due to

microbial testing. x Microbial monitoring as per defined frequency for Water & Environment. x Microbial testing as per the stability protocol for Hard Gelatin Capsule shells. Professional Accomplishments: x Involved in Installation and Qualification of demineralization plant for water

supply to 17 capsule manufacturing machines at ACG-Mumbai.. x Formulation of Preservative Free capsules to meet the export market demands

(USA, Czech, Ethiopia, South Africa etc.). x Conducted validation studies to reduce the release time from 120 hours as per

Indian Pharmacopoeia to 72 hours as per US Pharmacopoeia. Reduced the batch release time successfully with an aim to increase monthly turnover for dispatches.

x Reduced the loss due to batch failure and ETO treatment by increasing the sampling interval based on shifts by more than 50%.

x Achieved and sustained Zero Microbial Failure from Oct 2001 from 28% failure of finished product until Dec 2004by effective in-process control and GMP monitoring.

x Waste reduction by developing the procedure for recycling of unused gelatin cake that aids to optimize productivity

x Successfully undertook re-certification of ISO 9001 in the year 2002 by Bureau Veritas.

x Active participation in FORTIFY project as Process owner in re-defining the business processes for Quality Affairs and as a Key-user for Procurement function in the year 2012.

x Qualified as independent GMP auditor for Non-sterile preparations in September 2011 & Sterile preparations in beginning 2013.

Declaration: I hereby declare that all details provided above, by me, are true to the best of my Knowledge. PLACE: MUMBAI – INDIA