Qualitätsingenieur/in

NANO TOXICOLOGY CHEMISTRY OF NANO MATERIALS ,NANO SYSTEM DESIGN, POLY METRIC NANO MATERIALS ,NANO TECHNOLOGY IN MEDICINE ,REGENERATIVE ENGINEERING AND STEM CELLS , CLINICAL PHARMACOKINETICS, CHARACTERIZATION TECHNIQUES OF NANO MATERIALS, IMMUNOLOGY AND VACCINE TECHNOLOGY ,COMPUTATIONAL NANO TECHNOLOGY , CANCER NANOTECHNOLOGY.

BIO PROCESS, CHEMICAL ENGINEERING, MASS TRANSFER , ENGLISH, MATHS, PHYSICS, CHEMISTRY, CELL BIOLOGY,MICRO BIOLOGY, NANOTECHNOLOGY, BIOCHEMISTRY, BIO ORGANIC CHEMISTRY, MOLECULAR BIOLOGY , ENVIRONMENTAL SCIENCE , UNIT OPERATIONS , ENGINEERING GRAPHICS,

1. Performing qualitative and quantitative analysis of In process, Finished product and stability, process validation samples using high through put analytical instruments and documenting data online basis.

2. Performing the analytical method evaluation , method validation (Linerarity, recovery, specificity,LOD,LOQ,Forced degradation and precision.

3. Adherence to cGMP (current Good Manufacturing Practice), cGLP (current Good Laboratory Practice).

4. Good documentation practice as per GLP and cGMP guidelines.

5.Analytical method transfers and method validation.

6.Review of process validation protocol in coordination with QA.

7.Instrument Qualification, validation and temperature mapping.

8.Preparation revision and review of SOPs, IOPs, SPECs etc.

9.Collection of samples for testing and generation of reference number.

10.Corrective and Preventive actions as and when applicable.

11.Inception, testing of materials for in-process, finished product and stability samples.

12.Coordinating with contract testing lab for sample analysis and report.

13.Maintenance and calibration of measuring and testing equipment belonging to quality control laboratory in coordination with maintenance department.

14.Generation and maintenance of Quality reports.

15.Traceability of reserve samples and handing customer complaints relating to quality of products.

16.Ensuring effective implementation of EHS management system in the organization.

1. Physicochemical characterization of monoclonal antibodies using LC-MS and LC-MS tandem mass spectrometric hyphenated
techniques.
2. Analysis of samples usingMass spectrometry techniques -Synapt G2 Q-TOF with ion mobility LC-MS (Waters cooperation),
LTQ-Orbitrap-XL (Thermo Scientific)

3.Trained in troubleshooting system errors and performing basic preventive maintenance steps inclusive of calibration activities.

4.Deconvolution of MS Spectra and reporting the molecular mass data.

5. In-gel digestion studies as part of LC-MS based method development.

6. Protein purification by AKTA prime plus (Desalting technique).

7. Handling of Nano drop for OD measurements.

8. Buffer/reagent preparations

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