Quality Assurance

2 days ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- ALIDAC QA
- Job posted on
- Apr 24, 2025
- Employment type
- P-P7-Probationer-HO Staff

**ZTMP - REQUEST FORMAT**

Name : Garima Jha

BU : Quality

Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.

Contact # : 9173639189

**Basic Details**:
Position : Executive

Designation : Executive

Reports to : Deputy General Manager

Department : Quality Assurance

Location : ZLL-SEZ Oncology Injectable (Alidac)

No of Posts : 1

Role : Critical

Neev Level : 1

Details : Replacement

Position code : 60065126

Position Name : Executive

**Key Job Description: (Not more than 5 points in 6 lines)**

1. Review compliance against 21 CFR Part 11 requirements for electronic data generating systems.

2. Review SOPs, Checklists, Test procedures, Formats, Master batch records and Laboratory testing worksheets for identification of complex procedures/formats.

3. Review controls on computerized systems to ensure data generated from these systems is meeting the data reliability requirements. Review paper data, electronic data and audit trail of GMP activities at the site to check adherence and compliance level with respect to data reliability.

4. Perform walkthrough on the shop floor to identify the complexities in the processes which may lead to deviation from ALCOA+, and to take CAPAs as needed. Provide training to employees on the different topics related to data reliability and data security aspects.

5. Review several trends (but not limited to) like GDP error, OOS, deviation and lab incident and identify CAPAs as appropriate to prevent the departure from ALCOA+.

6. Perform periodic surveys (related to ALCOA+) from employees, analyze feedback received from survey, and to take CAPAs as needed. Review of investigations related to data reliability at site.

**Requirements**:
Qualification : M.Sc./M.Pharm.

Years of Experience : 03 to 10 Years

Experience in Zydus : 02 to 03 Years

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