Quality Assurance Program + GCP, GMP, GLP Certificates
Kriger Research Center offers you an OPPORTUNITY FOR A career IN clinical quality assurance Through AN EXCITING PROFESSIONAL DEVELOPMENT PROGRAM
The information below is provided to assist you to make an informed decision when choosing a career in Quality Assurance and the biopharmaceutical industry in general.
As you may know, recent manufacturing regulations such as 21 CFR Part 820.200
and the WHO TRS #902
have put a great demand on current pharmaceutical manufacturers to hire highly qualified quality assurance and manufacturing staff. The recent tightening of manufacturing regulations combined with and increased demand for GMP pharmaceuticals manufacturing is creating a major bottleneck in the pharmaceutical pipeline. The recent shortage of the flu vaccine in the United States is an excellent example of this.
In a recent survey of large scale biopharmaceutical manufacturers, 52% of the respondents stated that technical Quality Assurance staff training is a key area that needs to be dealt with today.*
Eric S. Langer (President of BioPlan Associates, Inc. a life sciences business information company) recently stated: “A lack of trained and experienced technical and production staff will have an impact on more than half of the world's biopharmaceutical developers and contract manufacturers in the next five years, and impact their ability to meet demand.” Click HERE for the full article.
In the next few years, many key patents will expire and major pharmaceutical companies (i.e. Pfizer, Eli Lilly, Merck, Apotex, GlaxoSmithKline etc.) will be looking to bring new pharmaceutical products off the laboratory bench and onto the pharmacy shelves.
This major boom in new pharmaceutical products will occur within the next two years. In order to accommodate this, the pharmaceutical industry is going to transition from pre-clinical R & D to large-scale production. In order to ramp up production and take on a new process rapidly, operations need to get the plant and equipment ready, and adding new, well-trained hires to run the process.
If you are seriously considering a career in clinical research as a Quality Assurance officer or pharmaceutical production technician, you know that the job requirements typically read "University degree, preferably in Engineering, Chemistry, biochemistry, Computer Sciences, Pharmaceutical, biology, biomedical science, Business Administration, microbiology, medicine, molecular biology, pharmacology with formal knowledge of ICH GCP guidelines, GMP, cGMP processes, knowledge and understanding of FDA and/or TPD regulations".
Not many people are aware of the fact that you shouldn't be an expert in pharmaceuticals to get into this most lucrative industry! This industry is all about regulations and rules that are easy to learn (no matter what background you have). When you know these rules and regulations, you are very attractive to any industry employer!
Another hurdle neophytes must overcome is “practical experience”. All QA job descriptions, list “one or two years experience” as a minimum requirement." Many, otherwise qualified candidates, often find themselves in a typical Catch-22 situation: You need experience to get hired yet how do you acquire the prerequisite experience without being hired?
Through extensive research and collaboration with hundreds of Sponsors, Investigational Sites, and CROs, KRC has created a unique training program to accommodate both industry specific knowledge and skills and practical clinical trial experience. This program is designed to provide training in ICH GCP, GMP, and cGMP guidelines, knowledge and understanding of FDA and TPD regulations. Most importantly, we provide practical, real world, clinical trial experience through our internship program. Our students participate in four of our current clinical research projects to get extensive practical, work related experience. This experience is critical to securing one's first position in this industry and is unique to KRC's CRP training programs.
Equipped with years of experience in creating and providing trainings, we developed an understanding that the only qualified instructors are individuals employed in the industry. To this end, KRC Inc. takes a very serious approach to choosing the most qualified industry professionals to lead our training programs. To be considered for a position as an on-line or in-class course instructor, a candidate must be currently employed on a full time basis in the industry, hold advanced academic qualifications and have proven relevant industry/training experience.
The combination of quality and accessibility of these training programs lead to our outstanding reputation in the industry and make us the number one corporate training choice for several leading international pharmaceutical companies and government agencies.Click HERE for testimonials.
If you feel that you possess the appropriate background, and are interested in pursuing this exciting and lucrative career, then we encourage you to review our demo session and/or register for the program.