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Manager Quality and Regulatory Compliance

1.00 to 6.00 Years   Chennai   30 Sep, 2019
Electrobrain Modern Technologies private Limited
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryChemical / Plastic / Rubber / Glass
Functional AreaQuality (QA-QC)Testing
EmploymentTypeFull-time

Job Description

Job DescriptionRole & ResponsibilitiesPurpose: -Lead the Quality and Operations for Production Chemicals (Pharmacopeia Grade Chemicals) and provide Technical and Regulatory support to drive the Chemical Business. Also ensure the compliance with respect to local laws, Import Export, Handling of Hazardous chemicals etc., which are applicable locally as well as internationally for doing the business.Responsibilities:

  • Implementation and monitoring of Quality Systems at manufacturing plant.
  • Preparation and Revision of all documents of QA, QC, Production and Operation.
  • New Vendor development and conduct audits as per the audit plan.
  • Conduct audits of the manufacturing locations as per plan. Support customer documentation.
  • Handling Quality Complaints. Coordinate for analytical testing and review of results. Co-ordinate with third party as well as in house testing lab for priority analysis.
  • Support local sourcing for identification of right source.
  • Lead ISO 9001 certification.
  • Regulatory support for compliance and documentation for manufacturing plant.
  • Dealing with Regulatory authorities which include preparation of documents like application, response on regulatory observation and visiting authorities as and when required.
  • Handling regulatory enquiries and prompt response to the customer.
  • Co-ordinate for Import and Export for handling Technical and ITC-HS Code related queries. Compliance with respect to Laws applicable for Handling Hazardous chemicals.

Keyskills :
compliance iso sourcing testing vendor ontinuousimprovementfacilitation hazardouschemicals vendordevelopment qualitysystems analyticaltesting

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