Lab QA

6 days ago

Ahmedabad Gujarat, India Zydus Group Full time

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 : Deputy Manager

Department : Quality Assurance

Location : ZLL-SEZ Oncology Injectable (Alidac)

No of Posts : 1

Role : Critical

Neev Level : 1

Details : Replacement

Position code : 60056568

Position Name : Senior Executive

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

Lab QA Role
- To review Raw Material, Packaging Material, In-process, Finished product, shelf life specification and its relevant Method of analysis and authorize the Testing work sheet. To review and approved analytical data of Raw material, Packaging material, In-process, Finished product, Stability study and Consumable materials in LIMS.
- To ensure the compliance and routine checks of current Good Laboratory Practices in the Quality Control department. To review chemical and microbiological analytical method validation, method transfer and Verification protocol and report.
- Handling, storage, withdrawal and reconciliation of stability samples in LIMS or out of LIMS. To review analytical data and trend summary reports of stability studies. To verify the outside laboratory samples and it’s reports.
- To ensure and review Change control, Deviation, LIR, OOS, OOT, OOC, CAPA, Trends and other investigations of quality control and quality assurance department.
- To initiate the departmental change control, deviation, CAPA, BDIF and investigation report. To review the qualification and calibration documents of QC instruments/equipment’s. To review stability protocol and approved the schedule related to quality control department.
- To prepare and review, stability schedule, other study protocol and their reports as per requirements. To prepare and review the qualification/validation documents related to quality assurance.
- To review the audit trial of the QC instrument or equipment, Stability chambers/incubators. Temperature and humidity data recording, review and approved for stability chambers/incubators and respective rooms.
- To participate in regulatory audit and its compliance.
- Notify event of QMS to customer and compliance team, response to their query/comments. Handling and trending of Oversight observation and its compliance. To provide the Quality index and Quality Management review data.
- To ensure calibration, Qualification and Preventive maintenance of incubators and chambers as per schedule. To ensure and review the Alarm logs, alarm acknowledgement, alarm trending and alarm assessment. To review Critical Quality Attributes trend data.
- To review the protocol, analytical data and report for in vitro Bioequivalence studies. To receive, store, control, reconcile, retain and destroy Investigational products for in vitro Bioequivalence studies. Review and approved the data in LIMS (Laboratory Information Management System).

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

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