Personnel

Technical person

Technical person, a person having STEM degree or person possess degree in lab-based science, technology, mathematics and engineering.

People who are attained STEM degree contain common set of traits. These traits make him ideal scientist, technologist, mathematician and engineer.

What do you mean by STEM?

STEM, this term often found in university advertisement, campaign, website, leaflet etc. but most of the people is not sure what does it mean. Here is the solution-

The term STEM define Science, Technology, Engineering and Mathematics and relevant subjects that are all under these basic subject.

Due to these subjects are not straight forward so series of subjects are undergo these subjects. Different terms are used in place of STEM as STREAM and METALS but the term STEM is more widely used.

Though these subjects are widely distributed but huge volume of vacancy found the respective field. From its beginning of STEM, various types of institutions are try to attract the students/people. STEM courses are the top most priority of the most of the counties to remove the shortfall.

STEM subjects the best option for the people who are searching for a longtime to be a resident to the other country/ immigration to expected country. This also beneficial for all type of students who want to study in higher level in different countries.

What are STEM subjects?

The STEM subjects [Science, Technology, Engineering and Mathematics] is not standalone, various type of subjects are closely related/derived from STEM so they are also STEM subjects. Here is the list of some STEM subjects-

• Aerospace engineering
• Astronomy
• Biology
• Biochemistry
• Chemistry
• Chemical engineering
• Civil engineering
• Computer science
• Electrical engineering
• Mechanical engineering
• Mathematics
• Physics
• Psychology
• Statistics

This list is far more extensive, the list will be more distributed based the basic criteria. This list my helpful for someone who are really searching for STEM subject and he will get som idea about the pattern of the STEM subjects.

The career prospects of some the subjects is more exclusive such Astronomy leads to the straight forward career patch than others subjects which tends to multiple career facility. Most of the STEM related subjects tends to more valuable sector such as Finance, Accounts, Aerospace, Cinema, Special Effects, Design and communications, Sportswear, consistency, Farming, Telecoms, Energy, Pharmaceuticals, Healthcare, Medical device etc.

What is the current situation in the practical field?

The history says, most of the STEM degree holders are male compare to Female. Introducing women in technical field is not satisfactory, the completion is less to female. More than Eight times male are more involve than female in STEM subjects related activities.

About 12% women are graduated in STEM degree; only 3% engage in practical field others are tend to alternative sector or stop to practice. The gender balance is dominant tend to pay gap in STEM field. More than 30% pay gab observed in in Australia at 2013. A remarkable initiative to be taken in this field to fill up the gender gap in STEM related subject.

How to become a Technical person?

1. Take post-secondary science classes

To enter into the professional STEM subject program, two years of college education is required. Most of the STEM subject’s candidate take 4 years of post-secondary education and achieved bachelor’s degree before applying any Doctoral program. As a STEM subject student you have to meet the requirements of the respective organization to get admitted for Doctoral Program.

2. Pass the Admissions Test

To enter into any doctoral program you have to pass the specific test. The specific exam includes various types of questions such as writing, critical reading, quantitative reading, critical reading, different type of process based on your STEM subject including one writing prompt. Exam occur all around the year, at least six times a year.

3. Earn a Degree of STEM subject

After passing the required test, you can apply for for Doctoral program of STEM subject, it may take 2 to 4 years based on subjects. If you want to gain practical knowledge, choose a program with 1 year internship.

4. Cultivate essential skills

To be successful in your next professional life then think deeply about your subject oriented skills, initially basic computer skill is required to run various type of thesis program and assignment oriented job.

5. Attend In plant Training

If you want to work in a factory related job/any job, you can apply for in plant training. Various types of organization offer this type of facility. If you select a program with 1 year internship, please escape this step.

6. Apply for license to practice in your state

You may face to license process based on your state require requirement. To start your career as profession STEM subject oriented job, license is mandatory in most of the state. Here you may face a single or multiple exam to prove your competency of the respective subject.

7. Pre assessment for interview

An interview process may arrange where SME[Subject Matter Expert]/ Assessors may present to conduct an interview. Number of SME/Assessors may vary state to state.

8. Attend interview

A representative will call you to attend an interview session based on your application with specific time and place.

9. Complete required training

If you want to work independently then you have to complete several training program based on your subject. Most of the SYTEM subject holder choose one or two years training program and on the job training program to facilitate his professional activities.

10. Responsible Technical person

After passing the exam and complete the required training program you can work independently or you can join a suitable position in any organization where you can create a value for yourself.

Also Read:

Qualified Person, How to become a Qualified Person?

Qualified Person (QP)

Qualified Person (QP), is mainly responsible to confirming/assuring the quality of certain batch of pharmaceuticals products. So this is very important that a Qualified Person (QP) must be in depth understanding of the pharmaceutical manufacturing, quality control and overall activities of the marketed products.

Qualified Person (QP), is the responsible person to certify a certain batch of pharmaceutical product prior to use for trail purpose or to send in the distribution channel for marketing.

This is not mandatory to understanding the manufacturing practice/process/procedure accurately but he must be understand the critical factors which may affect the critical quality parameters, safety and distribution/supply chain of the marketed products.

Qualified Person working area:

Most of the Qualified Person[QP] working in different pharmaceutical companies in various role mainly in product releasing activities but they also involve in national health sector, in such type of departments which hold different manufacturer authorisation to create various medicinal products mainly use in investigational purpose.

How do I become a Qualified Person?

1.0 Find a sponsor

A sponsor to be find out regarding individual guidance, training, prepare for final assessment, sponsor reporting about your eligibility to act as a Qualified Person[QP]. The sponsor also verify your application form signature required in various section of the application form.

Eligibility of Sponsor:

The sponsor must be the member one of the three professional body [The Royal Pharmaceutical Society, the Royal Society of Biology and Royal Society of Chemistry] and he must a QP [Qualified Person]. If your sponsor fail to meet criteria, then the sponsors form must be countersigned by the QP [Qualified Person] who will responsible to acting this issue about your engagement.

The sponsor must be involve in practicing QP who is known to you and he professionally known you in qualified period experience[1 year for Pharmacist and 2 Years for other professionals]. If you didn’t manage it, then you can use a Quality Assurance Line manager provided the report and countersigned by a QP.

Your sponsor is projected to:

Confirm that you have the sufficient knowledge of the subject that covered by the study guide. Certify the adequate experience.

A sponsor is actually a mentor for you. He will help you regarding your preparedness of the assessment, he will guide you to attain your success. He will confirm you that you possess the sufficient knowledge for final assessment. He will trained you in every step for apply the final assessment. Your Sponsor will provide you the necessary study guide and confirm that you possess the essential knowledge, skill, experience and personal attribute to act as QP[Qualified Person] at actual.

Role of an active sponsor

Role of the sponsor is the key to success of the applicant. This is very important for the applicant to find out an active sponsor because a sponsor is always involve the applicant training and application process. A sponsorship is always appreciated if role and responsibilities perform on great care. Regular interaction with the applicant is very important and this activity will be consider as mentor.

The sponsor Form and the application form is the first step of assessment process due to these two forms provide the documented evidence regarding employee background. The well documented application provide the positive impression to the Assessors.

The sponsor must have the experience and knowledge about pharmaceutical manufacturing, Quality Assurance and GMP[Good Manufacturing Practice]. Well conversant and up to date of the legal framework of EU and UK. Better understanding and relationship with professional bodies of MHRA & VMD [Medicine and Healthcare products Regulatory Agency & Veterinary Medicines Directorate].

The code of practice, role and responsibility of QP to be known including Study Guide and practical experience requirements. It is top most priority to be well familiar with the pharmaceutical business especially in Research and Development, production, Quality, Marketing and distribution.

An active Sponsor must possess good inter-personal skills and well communicator, having good contacts outside the company will add extra benefit. A better Sponsor will work as mentor who will provide the guidance to the aspiring applicant including positive direction.

Regular interaction is the key factor of the success, sponsor may communicate with applicant via various type of communication method [FB Messenger, WhatsApp,SMS,Emailing etc.] if unable to direct contact. Sponsor should monitor the daily activities of the applicant and prepare a progress report.

Sponsor’s report

Before submitting the application a sponsor form must be submit with the application. An application will not accept/review without sponsor report. A sponsor report must be different from applicant, sponsor report may not represent the same as applicant form.

A honest review is always create positive impression to the applicant. A sponsor report well be well described about the candidate. Every single details will be mention here. Applicant strong side as well as weak side, strength, personal attribute, development field need to mention very clearly.

The report is a key part of the sponsor’s input and it is not sufficient for you to simply provide a declaration of belief that an applicant complies with the requirements. It should be a critical and honest evaluation of the applicant’s technical and professional knowledge. It should also include information on the applicant’s personal attributes, including his or her strengths and weaknesses or areas for development.

A sponsor may indicate the following criteria of the Applicant but not limited to-

• Attitude
• Communications skill
• Extracurricular activities
• Flexibility
• Hobbies
• Open Mindedness
• Organizational behavior
• Peer coworker relationships
• Planning and organizing skill
• Professional integrity and ethics
• Problem solving capacity
• Verbal skill
• Reliability
• Working under pressure

This very important to notify the every single points on the report. Application primary assessment may be late based on the points and further clarification may be asked. Sponsor need to confirm that the applicant has gained the proper knowledge and experience in the Manufacturer’s Authorization and Manufacturer’s Authorization number with issue date to be mention with the application. A sponsor must declare the direct the working experience with the applicant. Different report will claim for multiple establishment.

2. Gain relevant experience

To be a QP[Qualified Person], a person shall be possess a certificate, diploma, or other evidence which can prove his formal qualification evidence which achieved after completion of University course, covering a duration at least Four Years of  theoretical and practical studies one of the listed scientific discipline:

• Chemistry
• Medicine
• Pharmacy
• Pharmaceutical chemistry
• Pharmaceutical technology
• Pharmaceutical biology
• Veterinary medicine

The minimum duration of the university course may be three and half year, where the course followed the theoretical and practical training duration minimum one year and training period will be six month in a pharmacy open to public collaborated by examination at university level will be preferred.

When two university course declared equivalent and one course extend to Four years but other course extend to three years then the three years course will be treat as diploma, the course shall include the listed basic subjects at least:

• Analytical chemistry
• Experimental physics
• General and inorganic chemistry
• General and applied biochemistry (medical)
• Microbiology
• Organic chemistry
• Pharmaceutical chemistry
• Pharmacognosy
• Physiology
• Pharmacology
• Pharmaceutical technology
• Toxicology

The QP[Qualified Person] experienced in practical required two years in authorized manufactures  and experienced may be reduced to One Year where the university course extending to Five years.

Overall, at least Two years expected is required in one or multiple facility which produce medicinal products but if you are pharmacist, you need only one year.

3. Apply through your professional body

The eligibility of QP, he must be the Pharmaceutical Scientist or Associate or Fellow or member of RPS[ Royal Pharmaceutical Society] who has qualified on the basis of formal course of study lasting not less than three years in fulltime or equivalent.

Minimum One year of practical experience is required for pharmacist, if anyone want to apply for QP eligibility but not registered a as pharmacist recommended to contact with QP officer for advice prior to apply.

If your Sponsor is satisfied that you are ready to apply then submit the application form with required fee [£700, may be change anytime], sponsors report and countersigned copy of your own certificates.

4. Wait for your initial assessment

If you application fulfill the requirement then QP officer will confirm you that your application has been received. Your application will be assessed be the designated assessor if the result goet to positive then you will be invited for interview session.

5.0 Attend your interview

Your interview will be held on London physically if situation is normal. Sometime virtual interview may held based on situation, QP officer will confirm you about this issue. If you passed the interview then you will be listed as QP person at your professional body.

Role and responsibility of QP

All of the pharmaceutical manufacturing authority and regulatory body ensure that the end user [Patients] are safe and the medicinal products meets its predetermined specification for sale or supply and confirm the basic requirements for safety, quality and efficacy.

• In a pharmaceutical company a QP plays a vital role certifying the batch confirms the predetermined specifications and its can be released for sale or supply or trial.

• QP is responsible to confirm that each manufactured batch has been checked in compliance with the laws in specific certifying authority.

• QP role and responsibility irrespective where the product will be sale/distributed/used.

• QP to be understand the demand of specific Authorization and confirm that PQS[Pharmaceutical Quality System] in place and satisfactory for the purpose.

• QP must understand the relevant steps of pharmaceutical manufacturing steps before certifying the specific batch.

• Must be full understanding of EU GMP guideline.

• QP must have decline to certify the specific products which process and procedure is unknown to him.

Career​​​​​ prospects of QP

The Career​​​​​ is widely distributed for the QP in various types of pharmaceutical industry as well as other designated industries who are involving in manufacturing of healthcare related products undergo to regulatory bindings. In pharmaceutical industry a QP can work in production, marketing, quality control, product development, quality assurance, project management etc. areas.

Resources to become QP and formal application process

Application form

Guidance notes for applicants and sponsors

Study Guide

Code of Practice for Qualified Persons

Sponsor Form

Download all Resource Here:

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