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Job as Executive – Regulatory in Winston HR Services

 

Clinical courses

Our clients are an ISO 9001:2000 BVQI certified company established in 2004 is situated at Changodar, Ahmedabad. All four state of art manufacturing units is certified by WHO-GMP, cGMP for. The WHO – GMP plant is approved by ‘National Drug Authority, Uganda, Kenya, Yemen, Ethiopia, Congo, Ghana, MCA (Zimbabwe), Namibia, Nigeria & Cote D’Ivoire.
They also cater to Srilanka, Philippines, Vietnam, Cambodia, Sudan, Myanmar, Mauritius, Costa Rica, & Latin America which we are at present exporting through Merchant Exporter. They regularly execute orders for many reputed companies for their export and domestic requirements e.g Zydus Cadila Healthcare Limited, Intas Pharmaceuticals Limited, Torrent Pharmaceuticals, IPCA Laboratories, German Remedies Limited, Claris Life sciences Ltd., Cadila Pharmaceuticals Ltd, Merck and Cipla. They are also manufacturing Alcohol/Codeine based products such as HB – Orange Plus.

Post: Executive – Regulatory - Pharma Company

Job Description:
Who have handled the FDA Product Permission, COPP, Loan Licence, WHO, Coordination with Narcotics Department: Licence/ Renewal, Alcohol/Efidryl, Codin Suflire: Storage, Coordination with Plant Head & Documentation,.
Liason with Government Bodies & Regulatory Authorities related with Product Licencing & Product Registration.
Monitoring and communicating new and changing regulations/update and anticipate their impact on the current and proposed approvals.
Communication and coordination with various department like Quality assurance, Quality Control, Formulation development etc.
Successfully accomplished the Plant Audit

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Please provide the following details:
1. Total Yrs of Exp:
2. Current Organization:
3. Current CTC:
4. Expected CTC:
5 Willing to relocate to Ahmedabad? : --------(Y/N)
6. Contact Number:
7. Notice Peroid:

Additional Information:
Location: Changodar, Ahmedabad
Education: Any Graduate/ Post Graduate
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production, Manufacturing, Maintenance
End Date: 31st January, 2015

If you are interested for the above position, please revert with your updated CV to winstonhrservices@gmail.com

Posted by,
Purvi Patel
Winston HR Services

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