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Glenmark Pharmaceuticals

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3.9

based on 2.9k Reviews

Video summary

88 Glenmark Pharmaceuticals Jobs

Assistant Manager

Glenmark Pharmaceuticals Ltd

3.9

based on 2.9k Reviews

2-6 years

Mapusa

1 vacancy

Assistant Manager

Glenmark Pharmaceuticals

posted 3mon ago

Job Role Insights

Flexible timing

Key skills for the job

SAP CO Clinical Data Management MS Office SAP Quality Management GMP Data Integrity

+ 2 more

Job Description

1. Ensurethe accuracy and reliability of cGMP data and data supporting regulatorysubmission.

2. Reviewthe data management process/procedures for both manual and electronic systemincluding data recording, data review, data archival, electronic datamanagement and ensure compliance to the relevant regulatory and industryguidelines e.g., 21 CFR Parts 11, 210, and 211, EU Annex 11, and FDAdata integrity guidance.

3. Reviewthe Quality Management system (QMS) events associated with data integrity andreliability.

4. Conductaudits and gap assessment based on regulatory requirement and guidelines andimplement CAPAs.

5. Toreview and ensure compliance to the procedures on Documentation and Review ofAnalytical Results , Review of Batch Production Records, Batch Release and Review of Data Completeness and Reliability for regulatory submission duringperiodic audits.

6. Escalatinggaps in cGMP data reliability to the site Quality Head and Corporate QualityAssurance and its impact on the data reported.

7. Escalation to Corporate SeniorManagement team based on the nature of the gap observed and its impact on thedata reported.

8. Toensure that a QMS event is raised within stipulated time period on being awareof a Data integrity event.

9. Preparemonthly reports on data reliability events and submit to Corporate QualityAssurance for Quality Management Review Meeting. Ensure implementation ofremediation measures based on gaps assessment.

10. Implementand oversee systems and procedures to ensure complete, consistent and reliabledata.

11. Ensureinitiation of CAPA at site based upon action identified during Data Reliabilityreview and its effectiveness check.

12. Reviewand approve Remediation plan, Retrospective Assessments related to DataIntegrity, including resultant corrective actions arising from audit findings.

13. Assesstraining program and conduct periodic training to employee from c GMP functionsat the site on procedures related to data accuracy, completeness andreliability.

14. Shall participate in self-inspectionand internal audit at site to verify the enhanced controls implemented for data accuracy and completeness.

15. Any other activity related to Data Reliability assigned bythe HOD.

16. ITApplications: Usage of QMS related T. Codes in SAP, Open Text, MS Office,Acrobat Reader, Departmental Drive, Skype, Outlook, HR Portal, ASPIRE LearningManagement System, Internet and TrackWise.

17. MaintainEnvironment, Health and Safety system as per ISO 14001:2015 & ISO45001:2018.

Employment Type: Full Time, Permanent

Read full job description

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What people at Glenmark Pharmaceuticals are saying

4.2

Rating based on 57 Assistant Manager reviews

Anonymous · Procurement & Supply Chain in Gangtok

Likes

Work life balance, well being, depends upon person capabilities if he or she willing to work in multiple window sections, accordingly management give them chance to work.