Assistant Manager @ ApicalGo Consultancy

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Assistant Manager

ApicalGo Consultancy
3 to 6 Yrs
Mumbai
11 months ago
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Job Description

Roles and Responsibilities

Accountabilities

1. Handling of market complaint, deviation, CAPA related activities like logging, investigation, closure, review etc.

2. Handling of change control activities like evaluation, review, workflow, closure etc.

3. Tracking of Global CAPA related activities, as applicable.

4. Review and approval of batch documentation for all dosage forms like BMR, BPR, MMF, VP & VR, and HTS & PFS etc.

5. Review of the deviation and CAPA and its effectiveness to ensure quality of the next batch of that product before batch release.

6. Coordination with cross functional team regarding complaint to find out the exact root cause and to identify effective CAPA.

7. Review of periodic trend of Market complaint, deviation and CAPA.

8. Implementation and effectiveness of SOP s applicable for team.

9. Support to Self-inspection and external Audits and provide compliance.

10. Review of market complaint investigation and CAPA and its effectiveness to ensure product quality and patient safety.

11. Handling of Deviation of LL & P2P products of contract manufacturing sites

12. Handling of Batch failure of LL & P2P products of contract manufacturing sites & To be prepared Batch failure status on Monthly basis.

13. Archival & review of APQR management system. Retrieving the APQRs from CMOs

14. Handling of preparation, review, and no. logging of risk assessment.

15. Handling of Trackwise and Cipdox software as rights provided in the application.

16. Review the batch failure/ recall if any.

17. Handling of NSQ/Query response etc.

18. Handling of Artwork related activity like review etc.

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Assistant Manager

Contact Details:

Company: HRServices
Location(s): Mumbai

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Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Assistant Manager @ ApicalGo Consultancy

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