India's pharmaceutical sector is expected to touch US$ 74 billion in sales by 2020. This means fresher will have promising career opportunities in the quality function, says Dr Rajkumar.
Given that healthcare is a basic human need, there is always a scope to innovate, discover and improve the availability of medicines for various ailments. With the global pharmaceutical industry expected to grow at a 3% - 6% CAGR over the next five years, the industry is focusing on addressing unmet medical needs, making medicines more affordable and optimizing manufacturing processes.
The industry is growing steadily throughout the world and growing particularly fast in markets such as India. Due to this rapid advancement the industry is seeing, the demand for professionals will continue to rise.
Quality, a critical factor
In many industries, quality is treated as a basic necessity. Consumers assume that a particular quality standard is being adhered to and then it becomes an afterthought. However, the traditional understanding of quality as mere absence of defects has undergone a paradigm shift. Today, the pharmaceutical industry considers quality with much more significance than other industries. During the production process, pharma manufacturers strive to comply with global regulations and ensure safe and reliable drugs – all this while keeping the production costs at optimum levels.
Quality job
Pharma companies look at quality through many components including reviewing processes quality, regulatory requirements and good manufacturing practices. In order to tackle these challenges, quality is typically broken into several functions including quality assurance (QA), quality control (QC) and compliance.
The broad scope of QA involves Current Good Manufacturing Practices (cGMP) and regulatory training, documentation, audit, validation and change controls. QA is related to process compliance and heavily oriented towards documentation. This allows external agencies to inspect the facility, to ensure that the product being manufactured complies with all global norms. Here documentation becomes very significant. What needs to be documented is decided by the QA. So both product quality and process quality are taken care of.
QC on the other hand has more to do with equipment handling, lab testing product stability and quality, reports and record maintenance for audits. Quality Control involves direct monitoring of the product. This means taking regular samples of the product and testing them for impurities, whether they are complying with the specifications of not, etc.
The career of an individual in the pharmaceutical industry starts as an individual contributor and then grows into a team leader and other managerial responsibilities as the career progresses.
Qualifications
The competency requirement essentially depends upon the product line that one is involved with. The educational qualifications required for a career in quality function of Active Pharmaceutical Ingredient (API) manufacturing will require knowledge of organic chemistry. Therefore, a B.Sc or M.Sc will be the expected educational qualification. On the other hand, the manufacturing of formulations will require knowledge of pharmacy. A diploma, B.Pharmacy or M.Pharmacy will be required here.
While educational qualifications are critical, they serve only as a base. Professionals will need to learn much more about cGMP and regulatory requirements of Food & Drug Administration (FDA) bodies. Quality standards keep on improving so professionals will have to keep abreast with the latest knowledge.
Career Outlook
India's pharmaceutical sector is expected to touch US$ 74 billion in sales by 2020 from the current US$ 11 billion, according to a PricewaterhouseCoopers (PwC) report. In addition, India is a large manufacturing hub for MNCs and demand from those customers is expected to increase. The demand for professionals will be on the rise. There will be a promising career opportunity for fresh graduates in the Quality function. In addition, companies are eager to hire students who have strong critical reasoning skills.
Growth path
A fresher starts as an individual contributor assisting in the lab, documentation, record maintenance or coordination across departments. He or she can grow into become a team leader managing small teams. As a next milestone, one can aspire to grow to head the QC or QA team at a plant level which will be a middle level posting. One can eventually become head of quality, a senior management position.
These days, given the importance of quality, cross-functional career paths are becoming more prevalent. Depending upon the aptitude of the individual, one can pursue a specialist career track and aspire to become head for the quality function. Alternatively, one can utilize strong grounding in the quality function to move across various business functions.
Quality is a dynamic field and will challenge professionals due to its ever changing nature. Quality standards are becoming more stringent which will force companies to inspect their quality systems. The demand for professionals in quality functions is likely to grow faster than the overall industry. Professionals entering the field will be required to have critical reasoning skills in order to meet standards while optimizing costs.
— The author advisor, human resources, Granules India
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