Session 1

INTRODUCTION 

  QUALITY ASSURANCE CAREERS WITHIN THE PHARMACEUTICAL INDUSTRY 

Welcome to KRC Inc. On-line training!

Who are we?

Kriger Research Center Inc. is an organization with broad expertise in the planning, execution and interpretation of research projects.  As our clients know, KRC Inc. serves as a partner in clinical research  with extensive experience in different phases of clinical trials.  KRC Inc. provides focused, comprehensive planning, which leads to a successful trial. Beyond the trial, we remain involved and committed to a development process that is custom-designed to our clients' needs.  We are committed to investing in ongoing training for our employees to ensure they are kept on the leading edge of new technologies. These training initiatives include interactions with academia, attendance at scientific conferences and meetings, training courses from experts in various fields, etc.

We have good working relationships with some clinical research recruiters, clinical research organizations (CROs) and pharmaceutical companies that  recognize us as a reputable institution. Some of them are posting their openings for clinical research positions on our site . 

Our Diplomas state that the student has passed a program on ICH GCP , Good Manufacturing Practices (GMP), Good Clinical Practices (GCP)  which is a standard requirement in this industry. 
 
The most important benefit of our program is student enrollment  in a volunteer position in real  projects  that give essential initial experience in the field. This is what potential employers like about us because our graduates know exactly what they are going to do in the industry, and that's what every employer actually needs. 

 

Why are there not enough Quality Assurance Specialists for the  on the market and why is it important to train the new specialists out of other professions with the right educational background?

In fact, the market is currently expanding faster than the production of new qualified professionals which inevitably creates a demand.  Most people are under the impression that the barriers to enter this industry are extremely difficult to overcome, but the truth is that everybody working in this industry had to start somewhere and as the industry grows positions need to be filled.  Now the question is: how will this be accomplished?  One way of filling the vacuum is to take specialists from other professions and turn them into professionals for this industry.  This has several added benefits of its own.   For instance bringing specialists from other professions or industries actually diversifies the workforce and brings  new perspectives to the biopharmaceutical industry.  This in turn is a source of innovation where multiple disciplines are being united and new perspectives are made more apparent. 

Of course, the need for training is obvious for specialists that are re-aligning their careers as well as  for individuals that are entering the industry as new graduates.  Most of the skills and knowledge required in positions such as Clinical Research Associates (CRA’s), Clinical Data Managers (CDM’s), Quality Assurance Specialists (QA) and Marketing Managers are not covered in university courses.  Even where an individual has been through a specially designed training program for the position through an academic institution, the training may not involve a practical component in which case the individual  still lacks  certain skills.  This should re-emphasize the importance of practical training programs for the biopharmaceutical industry.

The educational system does not appear to produce enough graduates to meet the demand for entry level positions like CRA, Data Manager Specialists, Quality Assurance Specialists and Marketing and Management specialists.  Skill shortages also affect the ability of regulatory agencies to keep abreast of scientific advances and to efficiently review the increasing number of new products. The diverse range of skills required along with the dramatic pace of change is not reflected in current university courses. The shortage of specialists could be felt in other areas too.  For example, bioinformatics requires a background in genetics, statistics, and software development, but most graduates lack such multi-disciplinary training. Also, there are no Canadian undergraduate degree programs in bioengineering; specialization options are normally offered within more traditional programs. 

Who can train Quality Assurance Specialists ? How valid is this certification?

At present, there is no professional designation for the positions of Quality Assurance Specialist  although these are valid and mid – high ranking positions in the corporate structure.    The ideal training environment would be in a research company itself  where the trainees can gain access to  real  practical experience.  Most if not all companies are very reluctant to hire individuals without any experience, so even 6 months as a volunteer is usually enough to get oneself  into an entry level position. 

Certification is a process by which a non-governmental agency validates, based upon predetermined standards, an individual's qualifications and knowledge in a defined functional or clinical area. The issue of being "certified" is confusing for many people who begin looking at Clinical Research as a career, for example: "CRA" and “CRC” are job titles not credentials. They neither imply nor require "certification".  The job function of CRA is not one that requires any special certification in order to perform it unlike, say, a CPA (Certified Public Accountant) or CMT (Certified Massage Therapist). Those are regulated job functions where people cannot call themselves "CPA" or "CMT" unless they have gone through specific procedures regulated by a governing body.

However, many companies use Certificates of Training as a screening mechanism for hiring or promoting employees. This results in multiple sources of training for Quality Assurance professionals, where the certifications are tied to the completion of different courses offered by various training providers.

A certification offered by a pharmaceutical research company would be recognized in the industry as a professional development course.  More important than this however, is the reference that backs the certification.  An individual with a reference from a pharmaceutical company will be held in a higher regard than an individual with a reference from an academic college.  In this industry especially, reputation is very important and goes a long way – professional references are usually the deal maker or breaker when a person is considered for a position.  

 QA Job Description

The traditional definitions of Quality Assurance are appropriate for the biotechnology industry. The standard systems and methodologies become the core for the function. The organization must understand not only the role of the Quality Assurance function but the responsibilities of the organization toward product quality. The Quality Assurance function establishes the systems, but everyone has a responsibility for quality. Quality must begin in me R&D area. Quality Assurance Specialist must understand its role and how he/she relates to the mission of the company. The ongoing process of the biotechnology manufacturing atmosphere makes it important to define the product by the process. Quality Assurance Specialist must take a positive, active role in this definition. There is absolutely no other way to guarantee the end product "fitness for use".

The role of Quality Assurance Specialist in the biotechnology industry is complicated by the process methodology and the need to define the product by the process. The systems and the support activities are the key elements to this definition. The validation of all aspects of the process becomes the Quality Assurance of the material. The means for determining the safety, efficacy, purity, and stability of the end material are related to this process definition.

Typical Work Activities

Typical work activities include :

Work Conditions

Entry Requirements

Knowledge of GLP, GCP, GMPs is a must. Excellent organizational and interpersonal skills. Prior experience in the pharmaceutical industry is preferred. Computer literacy - general word processor/database software. Excellent verbal and written communication skills.  Good interpersonal skills/team player. Ability to assess and identify GMP and quality-related issues. Strong attention to detail.  Demonstrated time management skills and the ability to work toward deadlines is required.
Experience/familiarity with Therapeutic Product Directorate (TPD) and Food and Drug Administration  (FDA) regulatory requirements. 

 University degree, preferably in  

Because of the ever-tightening government regulations on the manufacturing drugs  the need for QA specialists is increasing.

Training

Quality Assurance & Regulatory Affaires, ICH GLP, GCP, GMP Guidelines Professional Development Program is designed for Bachelor / Master (or PhD) Degree  in Engineering, Business Administration, Computer & Information Technology, Bachelor of Science in Business / Management , Chemistry, Biochemistry, Pharmacology and other BSc degrees.

This course is intended to give both general and specific information and guidelines to help establish, develop, and implement Quality Assurance in a biopharmaceutical manufacturing environment. This program is designed to provide a focused course of study for individuals seeking to position themselves for pharmaceutical and biotechnological industry as a quality assurance auditor, validation specialist or regulatory affairs officer. It will also provide knowledge and skills of excellence Good Laboratory, Clinical and Manufacturing Practices. This course provides a comprehensive overview of the roles/responsibilities of both the quality assurance auditor, validation specialist or regulatory affairs officer in pharmaceutical industry. This program was created to provide you with the key aspects, differences, challenges, job criteria and demands, and industry expectations.  Course content will focus on key concepts and information essential to effectively function in the pharmaceutical / biotechnological industrial arena. This course can open doors to new and exciting career opportunities in quality assurance as the demand for qualified and trained specialists is still growing. 

The development of the biotechnology, or "biotech", industry for biopharmaceuticals is exciting and rapid. Many new, small companies have been, or are being, established. The main emphasis of these companies is the development of the science associated with their particular products. There is a tendency to develop the science and leave the quality function in the background. For the ultimate success of the company, it is important to start developing the QA function in parallel with the science.

You will receive frequently by email, the KRC Inc. Newsletter including current positions in the field of this course. Also you can get help in your resume preparation. As a participant of this program you are encouraged to take part in Kriger Research Center   projects as a volunteer. This would enable you to earn an appropriate experience.

We would like to highlight once again the benefits of your enrolment in this program: 

1. You get the essential knowledge of everything you need in order to apply for Quality Assurance Positions. Along with in-class sessions you get free access to Interactive Training Programs On-line. You have complete coverage of all materials needed. Upon completion of this program you will pass on-line final exams and receive by mail or in person Diploma stating your new qualifications. 

2. You receive a specially designed Diploma stating the program objective:  “The International Conference on Harmonization (ICH): "Good Clinical, Laboratory, Manufacturing Practice (GCP, GLP, GMP) Guidelines, Quality Assurance & Regulatory Affaires in Pharmaceutical Industry”. This is essential in requirements to any position of Quality Assurance. (Look at the positions on our site or in our Newsletter - you will see that all of them require this knowledge). 

3. You participate and gain unique experience in real Practical Projects.  

4. You get reference letters on your project participation adjusted to your needs and reflecting all appropriate details of your active participation in full-scale practical projects. Without proper reference letters it is completely useless to approach any serious Pharmaceutical Company in order to get a job. 

 5. You get perpetual support of our research centre staff when you mention our institution in your resume as a place where your potential employer could obtain references. Almost always, prospective employer would make a call to collect references in personal phone conversation. 

6. When your prospective employer will call us for reference, we would reflect all the details of your research participation and appropriate qualifications. This could drastically increase your chances to get a job . 

7. You get active help in your resume editing. Remember, your resume is the first step to get a job. Now you would include into your resume as last entries, your participation in GCP, GLP, GMP Guidelines, Quality Assurance & Regulatory Affaires in Pharmaceutical Industry seminar and US / Canadian Experience in Real Project at Kriger Research Center Inc. 

8. You get on average every two weeks letter from us including fresh exclusive Positions that you can apply for, right away. 

9. You will get return on your investment in your education and training at KRC at least at 40 times more then you have paid and this in very first year of your work in Quality Assurance.  

 

 

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