Arch Pharmalabs has gained recognition as a world-class provider of small molecule process chemistry, custom synthesis services and full life-cycle API and drug intermediates manufacture for the global pharmaceutical industry. Generating revenues of USD 200 million, our India-based offering is supported by 2,400 customer-centric Archers, eleven certified facilities (including cGMP-compliant, US FDA- and EDQM-approved sites) and two state-of-the-art Process Technology centres.
Post: Regulatory Affairs Manager
Job Description:
To prepare Quality Management Reports for every month.
To fill customer questionnaire and sent it to Marketing dept.
To conduct Internal Quality Audit and follow-up of the same in various sites.
To conduct Vendor Audit.
To conduct contract analysis laboratory audits.
To review Systems, Applications, Product Data Process Related documents.
To Review the data, reports, documents of sitessuch as method validation reports, their raw data, process validation reports etc.
To prepare Corporate Trainning Module.
To prepare Standard Operating Procedure.
To provide new update on cGMP, GLP to out sites.
To review the open part DMFand response of quries.
To assist for Vendor management Sysytem
To update the database w.r.t customer audits and regulatory certification.
To assist for vendor management system.
Additional Information:
Exp: 5-7 years
Location: Mumbai
Education: B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D, QC
End Date: 19th May, 2011
Forward your resume at, jobs@archpharmalabs.com
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