GENERAL MANAGER-INDIA
YOURWAY INC
Total years of experience :16 years, 6 Months
Responsible for India P&L, Business development & Growth .
Ensure implementation of strategic plans to ensure medium and long term objectives are met
Providing Business Plan & Networking, Marketing Strategies, Sales and BD for
(1)Existing Indian SCM company looking for healthcare vertical set up .
(2)Opening of India branch for US & Russian CTMS MNC.
(3)FTZs in Middle East for Indian Pharma MNC.
(4)Pharmaceutical Manufacturing equipment Sourcing .
1. Ensure implementation of strategic plans to ensure medium and long term objectives are met.
2. Oversee the India business operations and responsible for implementation of best practice in distribution in line with GDP.
3. Ensure operational excellence by meeting and exceeding Company quality standards
4. Implement Company policies and procedures, ISO standards and other applicable regulatory guidelines.
5. Identify risks and propose solutions balancing business needs and costs.
6. Liaise internally with functional heads to ensure smooth operation of activities.
7. Responsible for financial control, budget and commercial matters.
8. Deliver on key performance indicators to achieve operational, financial and service targets.
9. Oversee relationships with major customers to ensure high service standards.
10. Deal with a wide range of problems that require well developed conceptual thinking and judgment to find solution.
11. Ensure Branch provides safe working environment for all employees and provides full training and support for the job.
12. Act as a representative of the function within the business and externally.
13. Lead and motivate team, hold regular individual and team meetings.
14. Ensure the local implementation of Client Technical (Quality) and Service Level Agreements (including aspects eg. Invoicing, billing, operations, reporting).
15. Manage and oversee service contractors for equipment maintenance and calibration.
General
1. Ensure compliance with national and international standards and legislation
2. Ensure timely and efficient management of records pertaining to Branch operations
3. Travel as reasonably requested by the Supervisor for the performance of duties.
4. To adhere to all company Policies at all times.
5. To undertake any other reasonable duties at the request of the VP APAC.
Responsible for Pan India operations, and CTMS/Depot and key accounts management
Responsibilities include operations, setting up the depot, getting all regulatory approvals and writing any SOP that are needed in order to meet audit requirements and gaining MOH approval and winning new business. Primary focus is transporting CTM globally as well as all other aspects to do with a clinical trial supply chain management storage, distribution, returns, reconciliation (API, ancillary supplies, components, electronic devices, vaccines, biological samples back to the central labs, etc.) One of the key functions is setting up depot network and to sell the service .
Project Management
Packaging & Labeling
Distribution and Logistics
Forecasting
Comparator Sourcing
Ancillary Supply Sourcing
CTMS
Layout Plan /design, Validation/calibration, Temperature mapping, MOH approvals of Depot .
Export, import of shipments of Pharmaceuticals/IMP/Vaccines/Hazardous/Dangerous/API/ Clinical supplies in Temp Controlled, 2-8˚C, Frozen, Dry-Ice, Liquid Nitrogen, Hazardous Materials.
(2) Worked as Pharmacist operating Assistant in WORLD COURIER (INDIA) Pvt Ltd., in their Clinical trial supply chain management (CTSCM) division, Hebbal ring road, Bangalore from Dec 2008 -May 2009 promoted as Depot Pharmacist in June 2009 and worked till 17-May 2012 in the same position
INDUSTRIAL VISIT
Undergone twenty five (25) days total of 150 hours of industrial training in formulation, QC, qa, safety, storage, and water treatment departments in CIPLA LTD, Bangalore in may 2006 as part of B.pharm curriculum.
DUTIES AND RESPONSIBILITIES AS DEPOT PHARMACIST.
(1) Handled around 140 clinical trial protocols Inbound, outbound, returns, reconciliation, destruction over the last 3 and Half years.
(2) Conducting Interactive web/voice response systems (IVRS/IWRS) transactions and IMP inventory management (shipment receipt/dispatch/quarantine/release) for most of the leading IVRS providers of client.
(3) . Supervised and managed team of seven logistic operator and four pharmacist operating assistant during the course of work.
(4) Extensive re-labeling (expiry update labeling, additional labeling, just in time labeling) experience for large study cutting across different clients.
(5) Fulfill all the legal regulatory requirements, set forth by the Ministry of Health.
(6) Maintain and assure compliance with applicable ICH, GMP and FDA Good.
Clinical Practices, local regulatory affairs, legal Requirements, and World Courier.
Standard Operating Procedures (or any other as required)
(7) Be familiar with the Protocol or any other related material of Clinical Products.
(8) Comply with World Courier Standard Operation Procedures, which contain all the specific instructions to take each step, as from the moment of reception until the shipment of the product in question.
(9) Verify and keep in order, all the documentation received, shipment arrival conditions, storage and all extra documentation related to each Product.
Hospital Pharmacist in MANIPAL HOSPITAL (MHS Pvt ltd) Airport Road, Bangalore from Oct 2007 - April 2008. Appointed as Hospital Pharmacist in April 2008 worked in the same position till Dec 2008
To assist the Regulatory Affairs Manager in following activities-
Preparation and review of eCTD Dossiers for USFDA, MCC and WHO.
Preparation and review of Registration Dossiers to French African, CIS, Asian, Latin American and South African countries according to country specific regulations.
Review and compilation of Chemistry Manufacturing and Controls information regarding description of the manufacturing, in-process controls, packaging procedures and stability data for the drug product.
Providing regulatory support to marketing team for regulated markets.
Review and drafting of artworks (outer pack, Label and package insert) for upcoming products.
Answering of queries arising from regulatory bodies.
PGDSCM
BACHELOR OF PHARMACY
10+2 ROSE PUBLIC SCHOOL (DBG) C.B.S.E 2002 1st CLASS
10th std ROSE PUBLIC SCHOOL (DBG) BIHAR C.B.S.E 2000 1st CLASS