Qc Micro

Department
- ALIDAC QC
- Job posted on
- Apr 29, 2025
- Employment type
- P-P8-Probationer-HO Executive

**ZTMP - REQUEST FORMAT**

Name : Garima Jha

BU : Quality

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

Contact # : 9173639189

**Basic Details**:
Position : Deputy Manager

Designation : Deputy Manager

Reports to : Deputy General Manager

Department : Quality Control Micro

Location : ZLL-SEZ Oncology Injectable (Alidac)

No of Posts : 1

Role : Critical

Neev Level : 1

Details : Replacement

Position code : 60047785

Position Name : Deputy Manager

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

Reviewer Role
- To prepare Media, Working Culture, Pure Culture and perform Growth Promotion Test. To install and execute qualification of Instruments/Equipment/System related to Microbiology section of Quality Control Department. To perform testing of Sterility, BET, MLT, Bioburden, Liquid particle count for In-process, Stability samples, Finish product samples & other samples received at microbiology and testing of packaging materials. To analyze water samples for microbial quality as per the defined SOPs/Protocols.
- Responsible for review of the laboratory records like analytical data, log books, calibration records etc. generated during the analysis. To prepare Specifications, Method of Analysis, Method validation protocol and report, Standard Operating Procedure as per requirement. To review and perform Method Validation, Hold Time Validation Study and Media Fill Protocols and Reports. To prepare documents and reports of microbiology section. To prepare and review Quality Performance Indicators like Trend Analysis of microbial monitoring data. To review all the documents, logbooks, reports and review & approve Vitek 2 reports of microbiology department.
- Responsible for coordination with Production, Engineering, Warehouse, Quality Assurance, department to align the quality control deliverables with respect to microbiological testing.
- Responsible for initiation and review of Change control, Deviation and CAPA as and when required. Responsible for log OOS, Incident and any notification if generated or required during review. Responsible for carrying out the primary laboratory investigations in case of any OOS, incident and noncompliance. To carry out investigation in case of Out of Trend, Out of Specification Results to find out root cause of the failure and prevent re-occurrence of the failure.
- To perform environmental viable monitoring in manufacturing and microbiology facilities. To perform non-viable monitoring in microbiology area.
- To participate in smoke study and media fill simulation studies in manufacturing and microbiology facilities. To review and perform Method Validation, Hold Time Validation Study and Media Fill Protocols and Reports.
- Responsible for conducting the training and qualification sessions for the staff & new entrants for various microbiological activities. To perform, review and matrix preparation of personnel qualification. To prepare, review and training schedule, training matrix, training questionnaire and training sequential log. To impart SOP and process related training to Quality control, Quality assurance and Production department personnel. To qualify the microbiology person by performing their analyst qualification and gowning qualification. To qualify the personnel for visual inspection.
- To co-ordinate for maintenance and calibration of lab equipment. To perform and review Calibration of instruments of microbiology section. To maintain and procure essential spares, consumables, media, reagent, glassware’s to minimize the delay and maintain inventory and issuance record. Carrying out vender audit, self-inspection and monitoring the compliance to action plans evolved therein.

Requirements:
Qualification : M.Sc. (Microbiology)

Years of Experience : 8 to 15 years

Experience in Zydus : 2 to 3 years

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