Kamada Ltd Work Values

Daily Duties at Kamada Ltd:

• Ensure compliance to cGMP for all operational activities. Monitor the formulated products against stipulated conditions mentioned in the Batch Production Record (BPR). • Sample, inspect and release of incoming material Both in microbiology and chemistry QA labs • Receive all chemicals and file MSDS (Material Safety Data Sheet) accordingly • Routinely execute analytical assays such as protein concentration via colorimetric kits, gel electrophoresis and staining, size exclusion HPLC, TOC analysis and Endotoxin, residual component analysis as well as other product specific analyses. • In house water system and clean steam collection, as well as USP testing of the water systems as the schedule dictate. • Environmental monitoring of clean rooms as the schedule dictates. • Train staff as requested and may serve as backup for microbiological QC methods, as Supervisor dictates • Monitor production, filling and packaging operations. • Conduct annual review of product quality. • Order supplies and perform the basic care of laboratory equipment • Calibration of IPQA laboratory instruments. • writing, revising, reviewing and approving of all Standard Operating Procedures ("SOP") • Give required support during validation studies. . • Personal responsibility for following safety rules, SOPs and cGMPs guidelines

What they like about Kamada Ltd:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

QA, CRA, CTA, Research, biothech, regulation affeirs, Pharmaceutical, Generic, sience, biology, biochemistry, mulecular, Internal Audits, Cell culture, microbiology, SOP, GMP, GCP, life sience, MS Office, cells culture, gene therapy, molecular biology, vascular cells, biotechnology, Endiogenesis, VSMC, signal transductins, GCPRs, TRKs, proteins, Enzymes, hormons, protein-expressiona-and-purification, DNA, RNA, elctrophoresis, cGMP Regulatory Compliance Support specialist, Vectors, transffection

Skills

1.Supervisor of all in vivo laboratory personnel and activities. Sole Study Director for all Good Laboratory Practice (GLP) studies, 2.Directed the group responsible for developing biological, chemical and sterilization qualification strategies. Indirectly supervised 10 - 15 peers and subordinates, 3.Determined all biological and chemical qualification testing of new and modified products or materials in compliance with industry guidelines., 4.Active participant with the development of domestic and international biocompatibility testing guidelines, 5.Keep abreast of international regulations and provide direction related to updated or new regulations or policies. E.g. GMP guidelines introduced to other departments , 6.Analyze and advise on quality approaches and techniques addressing product development, continuous improvement projects, and urgent issue task forces to ensure proper resolution and compliance, 7.Introduce of Risk assessment motives to QA web-reports led to early discovery of crucial problems (some systematic) which could cause disqualification of production batches. e.g. increase company efficiency, 8.Maintain library of regulatory guidelines, 9.Extensive meetings and trainings led Firm employees awareness to the importance of compliance to QA guides and by that lower the amount of invalid batches., 10.Positive atmosphere and encouragement of brain storming help in bringing out improvement ideas and to lift working motivation, 11.Managed a computer network system serving seven departments. (E.g. Manage registration tracking system including tracking submissions and updating registration database with Q-soft program – which I was Self study) . , 12.Molecular cloning technique: PCR, RT-PCR, Restriction digest, ligation, DNA/RNA gel electrophoresis, bacterial transformation, plasmid isolation and purification, plasmid transfection and generation of over expressed cell lines. Gene manipulation and d, 13.Protein analysis: protein expression in cell culture, SDS-PAGE electrophoresis, western blot analysis, isolation and purifications of proteins, co-immuno-precipitation technique, immuno-fluorescence technique and immuno-staining, 14.Culture experience: sterile work with various human and mouse cell cultures, bacterial cultures, cell transfection, treatment of cells with growth factors/inhibitors/drug, cell counts, 15.Bioinformatics: searching in GenBank, experience in genome/protein/cDNA databases analysis, BLAST and sequence alignment, genome comparison of various species, 16.Microbiology: diagnostic bacteriology, cultivation and isolation of bacteria, specialized culture media and culture conditions, testing antimicrobial susceptibility, 17.Microsoft office programs (e.g: Word. Excl, Power point, Access), Photoshop, Adobe Acrobat, Q-soft, Interwise

These are some of the questions we asked our climbers about their experiences with Kamada Ltd: