1. Instrument Calibration and Validation of Quality Control and Microbiology department
2. Sampling and analysis of raw material, in process sample and finished product
3. Microbiological analysis of raw material, in process and finished products like Sterility testing, BET analysis and Bioburden test.
4. Sampling and analysis of Raw water, Potable water, RO water and Distilled water
5. Culture preparation and maintenance of Micro-organisms (sub culturing)
6. Fumigation activity and Environmental monitoring of clean room
7. Routine microbiological analysis
8. Autoclaving of cleanroom aprons and cleaning clothing
9. Disposable of microbiological waste
JD for Quality Assurance - Department.
Job Description :
Perform the validation of Product & Processes.
Sampling of products to determine whether they meet specifications and quality standards and take corrective action if necessary.
Analyze quality assurance data and make recommendations for improvement.
Performing Calibration of all instrument- Equipment
Look after the Customer complaints.
Preparation, control and monitoring of internal and external quality requirements, including change control, deviation management as well as corrective and preventive measures.
Developing and implementing cross-organizational SOPs, monitoring the implementation and updating of all SOPs based on revised internal / external requirements
Planning, preparation and implementation of internal and external audits, development of audit reports, and training of proposed solutions to improve quality and tracking of corrective actions.
QMS, Schedule-M , ISO 13485 & GMP Documents.
Management of all market-related activities under the product recall process, convening and coordination of local recall committees, development of relevant reports.
Look after Health & Hygiene for Personnel & factory.
Any additional work as per requirement of organization
Qualifications and Skills