QA-qms

Department
- ALIDAC QA
- Job posted on
- May 12, 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 : Senior Executive

Designation : Senior Executive

Reports to : Associate Manager

Department : Quality Assurance

Location : ZLL-SEZ Oncology Injectable (Alidac)

No of Posts : 1

Role : Critical

Neev Level : 1

Details : Replacement

Position code : 60055060

Position Name : Senior Executive

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

QA-QMS Role
- To perform investigation of Deviation, Market complaint, Adverse Drug Events, Alert notification and product failures as per approved procedure.
- To ensure proper justification for the change proposed with its impact analysis, risk assessment and effectiveness check with its acceptance criteria. To complete the preliminary investigation and final investigation report within stipulated time.
- To do document historical check with inference by examining relevant data sources with respect to the nature of the event. To use appropriate investigation tool for investigation. To collect circumstantial evidence and considering for investigation. To interview personnel involved if needed in such a way that its relevant and adequate to identify cause. To review batch records & relevant records and identify the indicators of an event.
- To identify the root cause based on investigation outcome. To perform vertical and horizontal impact assessment based on the root cause.
- To coordinate with cross functional team for immediate action which may be deemed necessary to isolate the event, to limit any adverse effect on production, materials, equipment, areas, processes, procedures including discontinuation of processing or quarantine.
- To coordinate with contract givers for alert notification filing to the Agency, if applicable.
- To derive on appropriate CAPA in consultation with CFT for the event with a justifiable target completion date. To determine appropriate CAPA effectiveness plan. To Handle the Change control and check the effectiveness of the proposed change. To prepare, execute and review of Process Validation and Cleaning Validation.
- To prepare and review SOP’s in documentum software against current regulatory guidance. To do trend analysis of QMS (Change control, deviations, CAPA, market complaints, FAR, and Product recall ).
- To participate in Regulatory audit/ Customer audit and its compliance.
- To do trend analysis of repetitive issues. To discuss outcomes of trend analysis with the QA head and suggest appropriate CAPA. To have a focus on the investigation to get the consistency for improving the quality of investigation. To evaluate the change for its impact and recommend actions based on the change, to identify any additional members required for evaluation based on the change proposed.
- To maintain online entries in ZyQMS. To maintain APQR calendar/ schedule. To prepare and review the APQR. To monitor and prepare CPP report of product through validator and Minitab software. To prepare and review the visual inspection rejection trend in Minitab software.

Requirements:
Qualification : M.Pharm

Years of Experience : 5 to 10 years

Experience in Zydus : 2 years

**Experience / Exposure in (2 points)**:Must have knowledge and experience in injectable plant.