Dr. Seema Malik

Dr. Sudesh Bhure

Ph.D Chemistry from Institute of Science, University of Mumbai.

Highly Experienced Pharmaceutical Professional having more than 27 years of progressive and strategic experience in leadership role in leading Indian MNC,

Cipla Ltd. (1992-2015)
Glenmark Pharma (2016-2019)

Experience of QA and QC of API as well as wide range of Pharmaceutical dosage forms including Oral solid dose, Topicals, Liquid orals, Aspectically manufactured products, Inhalation products, Trans dermal patches, Creams and ointments.
Experienced of participating in regulatory inspections by USFDA, MHRA, ANVISA, TGA.

Experienced in responding to regulatory audit observations and tracking action to completion. Development and management of GxP Quality Systems Experienced in Investigation’s, report writing, CAPA and effectiveness of CAPA (OOS, OOT, Batch failures) experienced in CSV and GAMP5, Internal and External audits, Market Complaints Experienced in Automation and organising work so as to increase output (Automated calculations, automated log book). 25 plus international paper publications.

Dr. Seema Malik
Jagruti BVhatia

Suneeta Sule

MSC Analytical Chemistry Mumbai University
IRCA Certified ISO Lead Auditor

A professional with career span of 28 plus years in the respiratory field inclusive of six years of consulting Pharma companies, medical device manufacturers and capsule manufacturers Over two decade of experience with two of India's leading pharmaceutical companies in research and development for metered dose inhaler, Dry powder Inhaler and inhalation devices.

Experience of working with renown device design houses, medical device manufacturers, pharmaceutical companies, expedient manufacturer, capsule manufacturers and universities across Asia, UK and Europe.

Proven leadership role with problem solving, project de risking and sound technical abilities, experience of Risk assessment (FMEA), Root cause analysis and GAP analysis.

Experience of project coordination, design input, Evaluation, CE certificate of medical devices. Experience of technical lead for setting up MDI facility.

Professional Journey:
During her professional journey spanning more than 25 years was associated with wide range of companies and professionals. Medical device design house viz Radius, cambridge design partnership, kinneir dufort, UPS cambridge, coalesce, jay precision.

Medical device manufacturers like prespart ltd., Apta, Nypro and Rexam, Pharmaceutical firms like Cipla, Watson, Lupin, Biocon and Sprirolife Care capsule manufacturers e.g. capsugel, suheung and ACG worldwide.

Equipment / Instrument manufacturers like harro hoffliger, PAM and Copley scientific. Universities like University of Bath, BCP and SNDT university of Mumbai.

Dr. Seema Malik

Dr. Suhas R. Mangaonkar Ph D.

Sterility Assurance; Aseptic practices & Process;
Pharmaceutical / Medical Devices / Food / Cosmetics Microbiology and Biotechnology

About 25 years of experience in Pharmaceutical industry in R & D and Sterility assurance function, in lead role, in various professional organizations.



Skills & Expertise:
• Pharmaceutical Microbiology, Sterility Assurance
• Cell Biology. Cell Assay Development
• Therapeutic Monoclonal Antibodies
• GMP / GLP / Validation
• Regulatory Audits

Education:
Ph. D. Microbiology: From Bhabha Atomic Research Centre (BARC), 1995.
M.Sc. Biochemistry: From Grant Medical College, University of Mumbai. 1989

Work:
External faculty at ICT (UDCT), Matunga, Mumbai for Microbiology -2019

Mylan Labs Ltd., Head Aseptic process and practices, Sterility Assurance, Corporate Quality Assurance Injections - Year 2015 to 2019

Cipla Limited: Head Microbiology & amp; Cell Biology Corporate Quality Assurance - Year 2002 to 2015

Sandoz Private Limited: Head Microbiology, Quality Assurance - Year 1999 to 2002

Hoechst Marion Rousell: Research Scientist. Project drug discovery - Year 1995 to 1999

Dr. Seema Malik
Jagruti BVhatia

Jagruti Bhatia

Jagruti Bhatia is a Partner at Aarka Consultants and also serves on the management advisory boards of select healthcare start-ups. With a microbiology, transfusion medicine, Hospital Administration and a MBA background, she carries a rich experience of almost 30 years of which 22 years have been in healthcare consulting. She has led, advised and executed more than 450 – 500 odd projects across the healthcare consulting spectrum serving a prestigious list of clients in private and public sector both nationally and internationally.
Her previous roles have been as Senior Advisor, Director and Lead - helping set up Healthcare Consulting Practice for KPMG India; Senior Advisor - Healthcare for Godrej Interio, Godrej & Boyce and was the COO Consulting Services of a boutique healthcare architecture and management consulting firm eventually leading India, Africa and UAE operations.

She is an invited member in an advisory capacity with the Ministry of Environment & Forests, Maharashtra State; a certified Lead Assessor with the NABH, a trained JCI (Joint Commission International) professional and visiting faculty for various hospital & healthcare management programs. She has been an invited speaker at various seminars and conferences, having been featured in several industry magazines, on radio and television and is also a recipient of the BCPT – CAP Dorabji Tata Award for Excellence in Documentation and Knowledge sharing.

She serves on the Board of Trustees for the NGO FEC – Foundation for Environment Conservation where she works on tackling environment issues, propagating the practice of Agnihotra a process from the Rigveda for healing the atmosphere, soil and environment conservation, organic farming and healthcare capacity building in rural areas fulfilling her deep passion for social work.

Dr. Seema Malik

Dr. Seema Malik

MBBS, MD in Gynecology & Obstetrics, Post graduate in Hospital Administration from TISS, Post Graduate Diploma in Medico legal System and Masters in Business Administration.
Stellar career spanning more than 40 years in Medical Administration and Projects field with last position as Chief Medical Superintendent and Head of the department of 18 Suburban Hospitals under MCGM with total bed strength of 4500 beds.

Hand on experience in setting up the following facilities in peripheral hospitals
• Chemotherapy units
• Trauma Centre
• Neo natal intensive care unit
• Dialysis center
• MRI and CT scan facilities
• GenXpert Centers Provided following initiatives /services under Public private partnership (PPP) 2 hospitals namely Seven Hills Hospital Marol and BSES hospital Andheri
• Anesthesia Facility
• Intensive care unit
• Investigation services
• Kitchen Services
• Laundry services
• Housekeeping facilities

Setting up infection control committees namely bio medical waste and air borne infection control committee. Developing of standard operating protocols for cleanliness, zero outside prescription, zero outside investigation Policy, zero floor bed policy, zero scrap in hospital. Establishing linkage between teaching hospitals and peripheral hospitals for super specialty services for minimizing referrals of patients for peripheral hospital. Implementation of NABH in MCGM peripheral hospitals.

Dr. Seema Malik