Research Associate - QA at Glenmark Pharmaceuticals Ltd.
Job Description:
To plan, undertake and document study audits of the clinical studies to assess the integrity of the data and to determine whether the studies are planned, conducted and reported in compliance to GCP, SOPs and regulatory requirements.Review of study protocols.To undertake systems audits and document specific audits to determine whether procedures and systems within the Clinical Research Department are adequate, relevant to current operational practices and compliant to GCP, SOPs and regulatory requirements.
To undertake vendor audits.Prepare audit report and forward the audit observation to respective divisions.To prepare and reviews of SOPs.
Responsible for induction and training of new employees and ongoing training of SOPs and GCP/GLP for the existing staff.To implement change control and document control procedures
To plan, undertake and document study audits of the clinical studies to assess the integrity of the data and to determine whether the studies are planned, conducted and reported in compliance to GCP, SOPs and regulatory requirements.Review of study protocols.To undertake systems audits and document specific audits to determine whether procedures and systems within the Clinical Research Department are adequate, relevant to current operational practices and compliant to GCP, SOPs and regulatory requirements.
To undertake vendor audits.Prepare audit report and forward the audit observation to respective divisions.To prepare and reviews of SOPs.
Responsible for induction and training of new employees and ongoing training of SOPs and GCP/GLP for the existing staff.To implement change control and document control procedures
Candidate Profile:
Good English written and verbal communication skills, be organized, accurate, influential, persuasive, independent and detail orientated with proven problem solving skills and capability to work well as a team and individually.
Good English written and verbal communication skills, be organized, accurate, influential, persuasive, independent and detail orientated with proven problem solving skills and capability to work well as a team and individually.
Additional Information:
Experience: 1-2 Years
Location: Mumbai
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D, QA
End Date: 30th Sept., 2011
Experience: 1-2 Years
Location: Mumbai
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D, QA
End Date: 30th Sept., 2011
Apply/Send Your Resume at, refer_mahape@glenmarkpharma.com
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