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95 Glenmark Pharmaceuticals Jobs
Assistant Manager
Glenmark Pharmaceuticals
posted 2mon ago
Job Role Insights
Flexible timing
Key skills for the job
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
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Top Glenmark Pharmaceuticals Assistant Manager Interview Questions
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What people at Glenmark Pharmaceuticals are saying
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.
- Salary - Excellent
+6 more
Dislikes
Everything is appropriate nothing is there to dislike.
Assistant Manager salary at Glenmark Pharmaceuticals
reported by
351
employees
with 9-18
years exp.
₹7.3
L/yr - ₹19
L/yr
54%
more
than the average Assistant Manager Salary in India
View more details
What Glenmark Pharmaceuticals employees are saying about work life
based on 2.9k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
Glenmark Pharmaceuticals Benefits
View more benefits
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