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Career in Quality Assurance


Quality Assurance

Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled".[1] This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control and has been referred to as a shift left since it focuses on quality earlier in the process (i.e., to the left of a linear process diagram reading left to right).[2]

The terms "quality assurance" and "quality control" are often used interchangeably to refer to ways of ensuring the quality of a service or product.[3] For instance, the term "assurance" is often used as follows: Implementation of inspection and structured testing as a measure of quality assurance in a television set software project at Philips Semiconductors is described.[4] The term "control", however, is used to describe the fifth phase of the Define, Measure, Analyze, Improve, Control (DMAIC) model. DMAIC is a data-driven quality strategy used to improve processes.[5]

Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a product, service or activity will be fulfilled.[3] It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention.[6] This can be contrasted with quality control, which is focused on process output.

Quality assurance includes two principles: "Fit for purpose" (the product should be suitable for the intended purpose); and "right first time" (mistakes should be eliminated). QA includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes.[7] The two principles also manifest before the background of developing (engineering) a novel technical product: The task of engineering is to make it work once, while the task of quality assurance is to make it work all the time.[8]

Historically, defining what suitable product or service quality means has been a more difficult process, determined in many ways, from the subjective user-based approach that contains "the different weights that individuals normally attach to quality characteristics," to the value-based approach which finds consumers linking quality to price and making overall conclusions of quality based on such a relationship.


What do they do

Quality assurance is a process used to learn if your product or service is up to standards, and whether you are giving customers the kind of product or service that will keep them returning. The idea is to deliver a product or service that consistently keeps up a high quality. It’s a proactive approach where defects are detected before a product or service goes public. This is vital to customer satisfaction. When customers are happy, your company is in a much better position to do well.


How Quality Assurance Works

Quality assurance is a system intended to demonstrate to company leadership and to the public that a product or service is up to standards of quality, often set by industry or regulators. It is sometimes called quality control, although quality control has more to do with the product after it’s made. Quality control became commonplace in manufacturing in the 1920s as a way to define and control the quality of products. In the 1950s, quality assurance became important in public health and public safety.

Today, quality assurance measures the standards that go into a product or service before it goes out to the public. Quality assurance uses auditors, sometimes independent and sometimes in-house, to evaluate the methods that go into making products and providing services. When a company has a good quality assurance team, that lets corporate management, customers, regulators and government officials know that a product or service meets quality requirements.


Why Companies Use Quality Assurance

Quality assurance should never be overlooked in order to finish a job in a hurry. The process lets you know if you are using your resources the way you should. You don't want to cut corners with any part of your product’s quality. Cutting corners could result in lost client faith, shrinking profit margins and eventually, your company’s ability to attract talented employees. Good quality assurance procedures allow both company owners and employees to take pride in their work.


Benefits to Quality Assurance

Quality assurance helps a company meet its clients’ demands and expectations. High quality builds trust with your customers, which, in turn, makes you competitive in the market. It saves costs and fixes issues before problems become larger, and it helps to set and maintain quality standards by preventing problems to begin with. Investing in quality assurance is indispensable in many industries today. It is most effective when it’s in place from the start. When quality assurance is done right, it provides confidence, tests the product and lets companies market their products with few worries.


Reduces Cost and Waste

Having quality assurance in place is especially helpful to small businesses. It allows them to reduce extra costs that come with retesting, replacing and reselling faulty goods. When customers aren’t satisfied with a company’s products, the backlash can damage the company’s reputation, and negatively affect future products and even the entire company. Quality assurance might also save a company money in legal expenses, especially if its product isn’t up to industry standards.


Creating and Managing a Team

If you choose a specific employee to do quality assurance, look for someone with the ability to handle repetitive tasks, be perfection-driven and willing to look deep into the root of an issue. The effort should be well-organized, with requirements for each case specified clearly. Track progress regularly and provide the tools needed to do the job well.


Skills

 determining, negotiating and agreeing on in-house quality procedures, standards and specifications

 assessing customer requirements and ensuring that these are met

 setting customer service standards

 specifying quality requirements of raw materials with suppliers

 investigating and setting standards for quality and health and safety

 ensuring that manufacturing processes comply with standards at both national and international level

 working with operating staff to establish procedures, standards, systems and procedures

 writing management and technical reports and customers’ charters

 determining training needs

 acting as a catalyst for change and improvement in performance and quality

 directing objectives to maximise profitability

 recording, analysing and distributing statistical information

 monitoring performance

 supervising technical or laboratory staff.


Typical employers of quality assurance managers

 Manufacturing companies

 Engineering companies

 Automotive companies

 Textile companies

 Pharmaceutical companies

 Processing companies

 Banks

 Universities

 Government departments


Qualifications and training required

A degree or higher national diploma (HND) in any subject is acceptable for entry into the profession. However, employers prefer qualifications in subjects such as business studies/management, materials science/technology, food science/technology, textile technology, polymer science/technology, process engineering, production engineering, physics or mathematics.

For some positions, a postgraduate qualification or a technical degree background is necessary. You can read our article on engineering postgraduate study to explore your options.

Relevant work experience is highly desirable and may be gained via final-year project work, work shadowing, degree sponsorship, vacation work or industrial placements. Take a look at our list of engineering employers who offer industrial placements and summer internships.

Membership with the Chartered Quality Institute (CQI) can help to show your commitment to your field and will provide opportunities for continuing professional development (CPD), as well as networking events.

Key skills for quality assurance managers

 Confidence

 Excellent technical skills

 Good numerical skills and an understanding of statistics

 Leadership skills

 Planning and organisation skills

 Communication and interpersonal skills

 Problem-solving skills

 Teamworking skills

 IT skills


Salary

Average Quality Assurance (QA) Specialist Salary in India

₹627,058

Avg. SalaryShow Hourly Rate

₹51,297

BONUS

₹2500

- Need of QA & QC

- Where and when to apply - Current norms and regulations (for both compliance and non-compliance) - Testing tools and techniques - Overcoming QA problems and fixing methods

All the above as well as practical knowledge about the subject has been included as case studies, practice modules, e-sessions and lectures, e-classrooms and discussions etc. The sole aim remains to make ready candidates with ample and appropriate knowledge about varied quality issues, concerns, industry needs, techniques, legislative norms and precise knowledge for identifying and overcoming quality related problems arising at work place. With this knowledge the participant can confidently aim to apply for and be a part of healthcare production units, quality check divisions of manufacturing plants and even quality auditing boards and regulatory authorities.

Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical industry ((International perspective of USA, WHO, ICH & Europe / Australia & New Zealand / Gulf Countries (GCC) / Canada / Africa / India etc)

Module 2 : Qualification and Validation

Module 3: Quality Assurance and Quality Control- Possible Problems and Fixes

Module 4: Types of Quality Testing (models, types, procedures etc.)

Module 5: Quality Testing Tools and Techniques

Module 6: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000

Module 7: Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas

Module 8: Setting up Quality Control Checks, Inspections and Audits

Module 9: Documentation, Good Documentation Practices, SOPs, Protocols, etc.

Module 10: Addressing Internal and External Quality Issues – Complying with Govt. regulations

Module 11: Computer System Validation

Module 12: Laboratory demonstration of QAQC practicals and Instrument Handling

Module 13: Case Studies


Eligibility

Graduation in Pharma/Medical/Biomedical/Biotechnology/Microbiology/Science and Candidates appearing for the final year of Bachelor's degree/equivalent qualification exam or awaiting their results, are eligible to apply.

Programme Duration

Minimum duration to comeplete this program is 1 year and maximum is 2 years.

Registration

The registration dates for this bi-annual programme run by the institute are updated timely on the webpage. The Training sessions and webinars are scheduled preferably on weekends depending on the availability of visiting faculty. Effective E-learning tools incorporated into the design of the webpage make the course lectures, videos and study material easily accessible. This gives huge window of self-regulated and self-paced performance to the participants. Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.

All the participants are expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma in Pharmaceutical Quality Assurance and Quality Control by Faculty of Good Manufacturing Practice, IGMPI. For all the above mentioned modules elaborate course material, self-assessment assignments and project work details would be provided by the Institute from time to time. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading healthcare companies across the globe. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc. In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy, Biocon etc.

Future career prospects of Pharmaceutical QA & QC Training

QA & QC are quiet essential parts of pharmaceutical, biotech and all other verticals of the healthcare industry. the two find application in other industry types as well but since healthcare is the most dynamic industry and the one concerned with health and well-being of the population, QA & QC are highly treated and most regarded divisions to settle in. thus the career prospects and opportunities are never ending.

With this important role in the industry, sense of responsibility is expected from the joining employee and of course a thorough and complete knowledge of the work area. Our e-course works to prepare candidates for the same. The interactive e-course thus has been tailor made to suit needs of employed as well as yet to be employed candidates targeting to take over the quality assurance and quality control divisions of the industry.


Preferable institutions

1.Indian Institute of Quality Management

Government college

8a, Malviya Nagar Industrial Area, Malviya Industrial Area, Malviya Nagar, Jeypore, Rajasthan 302017


2.Indian Institute Of Quality Assurance

Door No. A - 44, Bharat Nagar, Grant Road, Mumbai - 400007


3.Defence Institute of Quality Assurance (DIQA)

5th Cross Rd, S K Garden, Chinnapa Garden, Benson Town, Bengaluru, Karnataka 560045


Frequently asked questions

Q1. What if organization is growing so fast that fixed QA processes are impossible? A: This is a common problem in the software industry, especially in new technology areas. There is no easy solution in this situation, other than... 1. Hire good people (i.e. hire Rob Davis) 2. Ruthlessly prioritize quality issues and maintain focus on the customer; Everyone in the organization should be clear on what quality means to the customer.

Q2. How is testing affected by object-oriented designs? A: A well-engineered object-oriented design can make it easier to trace from code to internal design to functional design to requirements. While there will be little affect on black box testing (where an understanding of the internal design of the application is unnecessary), white-box testing can be oriented to the application's objects. If the application was well designed this can simplify test design. Q3. Why do you recommended that we test during the design phase? A: Because testing during the design phase can prevent defects later on. We recommend verifying three things... 1. Verify the design is good, efficient, compact, testable and maintainable. 2. Verify the design meets the requirements and is complete (specifies all relationships between modules, how to pass data, what happens in exceptional circumstances, starting state of each module and how to guarantee the state of each module). 3. Verify the design incorporates enough memory, I/O devices and quick enough runtime for the final product.

Q4. What is software quality assurance? A: Software Quality Assurance, when Rob Davis does it, is oriented to *prevention*. It involves the entire software development process. Prevention is monitoring and improving the process, making sure any agreed-upon standards and procedures are followed and ensuring problems are found and dealt with. Software Testing, when performed by Rob Davis, is also oriented to *detection*. Testing involves the operation of a system or application under controlled conditions and evaluating the results. Organizations vary considerably in how they assign responsibility for QA and testing. Sometimes they're the combined responsibility of one group or individual. Also common are project teams, which include a mix of test engineers, testers and developers who work closely together, with overall QA processes monitored by project managers. It depends on what best fits your organization's size and business structure. Rob Davis can provide QA and/or Software QA. This document details some aspects of how he can provide software testing/QA service.

Q5. What is quality assurance? A: Quality Assurance ensures all parties concerned with the project adhere to the process and procedures, standards and templates and test readiness reviews. Rob Davis' QA service depends on the customers and projects. A lot will depend on team leads or managers, feedback to developers and communications among customers, managers, developers' test engineers and testers.

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