Senior Manager (Data Reliability Officer)- Quality Assurance in Glenmark Pharmaceuticals Ltd.

Job Posted on Jan 17, 2023

Recruiter Type:Company
Company Name:Glenmark Pharmaceuticals Ltd.
Contact Person:HR
Required in:Formulation
Job Department(s):Quality Assurance
Job Title:Senior Manager (Data Reliability Officer)- Quality Assurance
Qualification:Master of Pharmacy / M.Sc
Job Details:Job Responsibility
1. Has overall knowledge of laboratory controls and manufacturing operations of drug product.
2.Has experience of handling electronic data of manufacturing operation and laboratory system.
3.Implement and oversee systems and procedures to ensure complete, consistent and reliable data.
4.Review the data management process/procedures for both manual and electronic system including data recording, data review, data archival, electronic data management and ensure compliance to the relevant regulatory and industry guidelines e.g., but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance.
5. Review and approve the Quality Management system (QMS) events associated with data reliability and accuracy.
6. Ensure the accuracy and reliability of cGMP data and data supporting regulatory submission.
7. Conduct audits and gap assessments based on regulatory requirements and guidelines and implement CAPAs. To review and ensure compliance to the procedures on SOP for 'Documentation and Review of Analytical Results', SOP for 'Review of Batch Production Records, SOP for 'Batch Release' and 'SOP for Review of Data Completeness and Reliability' during periodic audits.
8. Escalating gaps in cGMP data reliability to the site Quality Head and Corporate Quality Assurance Head, Compliance.
9.Escalation to Corporate steering committee, based on the nature of the gap observed and its impact on the data reported.
10.Prepare monthly reports on data reliability status at the site.
11. Ensure initiation of CAPA at the site based upon action identified during Data Reliability review and its effectiveness check.
12. Include gap assessment and remediation plan, if any, for data reliability in the Quality Management Review at both site and corporate level.
13. Assess training program and conduct periodic training to employee from c GMP functions at the site on procedures related to data accuracy, completeness and reliability.

Knowledge and Skills (Functional / Technical)

Effective communication (both written and verbally) and interpersonal skills. Demonstrated "change agent" skills; inclusive of influence management, project management, vision development, and people motivation skills. Demonstrated ability to identify and leverage internal and external opportunities.
Good experience as project lead or similar position Knowledge on relevant Guidelines USFDA inspection exposure

Experienced in Lab & Manufacturing Operation (OSD and SSD), QMS, Review of Electronic data, Regulatory requirements
Regulatory Exposure:Required
Audit Experience:USFDA
Experience:14 -16 years
Last Date:25/01/2023

Click Here

Write a Powerful CV

Click Here

Get App for News Updates

Scan to Download

Android App
Android App

Recent Articles