Darshana Shah

Experience

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  ACG World

  Apr 1997 - Dec 2004

  Officer Quality Assurance

  Responsible for smooth functioning of microbiology departmentResponsible for timely testing and release of raw material and finished product.Undertaken and successfully completed validation and implemented: Microbial testing of finished product to reduce the lead times for release.Performed validation of Preservative efficacy testingInvolved actively in the development of Preservative Free CapsulesInvolved actively in the development of HPMC capsulesResponsible for planning internal ISO audits and GMP Audits. Ensuring timely CAPAs and closure of audits.Responsible for ISO Coordination with all HODs. Successfully conducted the ISO 9001:2000 surveillance audit in the year 2002 in coordination with Bureau VeritasMonitoring Organizational Stretch Goals (Objectives) on quarterly basis with each department and highlighting the deviations or shortfalls.Group company GMP audits (UCL Dhanau and ACL-Shirwal)Actively involved in the SAP implementation in 2004. Show less

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  Ajanta Pharma Ltd

  Dec 2004 - Oct 2005

  Assistant Manager Drug Regulatory Affairs

  Leading a team of 12 officers in Regulatory affairsEnsuring timely submission of registration dossiers as per Sales & Marketing requirement.Technical information for tender participation.Responsible for Site Audits and Compliances.Maintaining SMF of Paithan and Chikalthana plantDesigning Batch Manufacturing RecordTechnical support to Site QA and QC. Prepared Paithan Plant for UNICEF and MSF audits. Responsible for internal audit of Formulation and Development, Stability cell, Analytical Method Development department and plants. Show less

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  IDA Foundation

  Jan 2015 - Apr 2017

  A) Regulatory Affairs• Ensure that there are no stock out situations due to regulatory activities• To provide regulatory expertise to all involved functions – locally and globally• Life cycle management of marketing authorizations of products (responsible for variation submissions, renewal applications, annual reports) • To finalize the strategy for variations • Training to group members – regulatory related / systems related.• To support all local and global initiatives• . To check on all activities as per the defined procedures / as per defined systems.• Assessment of the documents required for preparation and compilation of variation package / dossier.• Review of marketing authorization applications wherever required.• Review of annual reports / variation / renewal applications wherever required.• Review of documents required for submission of response to the deficiency letters.• To support tender related activities• Responsible for strategic decisions with respect to Registration policy for the entire organization.B) Quality Assurance• Part of the strategic team to design and review Quality Policies.• 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 & disinfectant Show less 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 GuidelinesJob Responsibility:• Part of Management Team in IDA Foundation India office since Dec 2007.• Responsible for overall functioning of Quality and Regulatory Affairs department in India and leading a team of 18 personnel.• Functionally reporting to Quality Affairs Director in Amsterdam• Resource Management for Regulatory affairs, Quality Control and Quality Assurance IDA India.• Responsible for annual departmental budget & review and revise forecast on bi-annual basis.• Abreast Management (India and Amsterdam) on departmental activities through Monthly reports, Balance Score Card and Annual Report.• Bring awareness to staff and suppliers/customers/stakeholders when necessary on IDA Quality system.• Responsible for compliance in operational practices in India office Show less

  • Manager Regulatory and Quality affairs India

    Oct 2005 - Apr 2017

  • Head Regulatory and Quality Affairs - India

    Jan 2015 - Mar 2017
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  Sourcing Solution Technologies

  Mar 2017 - Jul 2018

  Pharmaceutical Consultant

  A Quality Assurance and Regulatory Affairs professional having more than 23 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 Gap Analysis and GMP audits as per WHO, PIC/S, EU 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.Expertise in Green Field Projects – Designing Quality Systems, Quality Plan, End to End Documentation & SOP’s for Facility, Validations and Qualifications (HVAC, Water system, Utilities, Equipment & Process Validations & Technology Transfer protocol). Show less

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  MicroSynergy Pharmaceuticals

  Jul 2018 - Sept 2019

  Head Of Quality Assurance
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  IDA Foundation

  Jul 2020 - May 2023

  Manager Operations

  Responsible for overall operations including inbound, outbound, inventory and emergency health kitting solutions for World Health Organization on behalf of IDA Foundation. KPI and performance management of 3PL partner.

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  Hellmann Worldwide Logistics

  May 2023 - now

  Quality Manager