Job Title: Manager - QC (Micro)
Purpose of Job
Responsible for handling QMS, Review and Planning for QC Micro department.
Skill Required
Handling of Change Control, Deviation Investigation, OOS Closure, Microbial Data Deviation Investigation, Incident Management
Roles and Responsibilites
Responsible for review, investigation and documentation.
Review of DRS, Documents and data related raw material, packing material and consumable material, reagent & volumetric and water analysis.
To execute and support in investigation of LIR, OOS, OOT, OOL, NCR and Deviation
To execute and support in change control Execution of gap analysis of QC system and effective implementation of cGMP and regulatory requirements
Preparation, review and revision of documents as and when required. To verify calibration/ verification/ qualification/ cleaning/ monitoring activities of various QC instruments/ equipments as per schedule
To impart training on different tests to new employees and student trainees
Responsible for general work place cleanliness, proper equipment management and adherence to all approved SOPs and GMP procedures
To Review Microbiological test records like CCIT, study/validation documents, BI etc. Method Validation protocol/Study preparation and execution of BET, Bioburden, Sterility, CCI, Sub Visible Particles Test. Trend Preparation. Handling of Incident. Handling of Software like SAP, LIMS, NIV DAS etc. Media Fill observation
Qualification Required
M. Sc. Microbiology B. Sc. Microbiology
Relevant skills / Industry experience
Handling of Change Control, Deviation Investigation, OOS Closure, Microbial Data Deviation Investigation, Incident Management
Relevant professional / Educational background
M. Sc. Microbiology B. Sc. Microbiology
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213