JOIN USQuality within pharmaceutical industry is a dynamic and challenging field due to its ever changing nature, observes Dr Rajkumar.
The global pharmaceutical industry is valued at more than $800 bn and is expected to grow at a three to six percent CAGR over the next five years. Therefore, maintaining quality at all steps and levels of the drug manufacturing process is critical for the industry.
Due to favorable factors such as government policies, increased per capita income and greater health awareness, the pharmaceutical industry is growing steadily throughout the world and particularly fast in markets such as India. Due to the growth of the industry, the demand for professionals will continue to rise.
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. The industry is focusing on addressing unmet medical needs, making medicines more affordable and optimizing manufacturing processes.
Why is quality crucial?
In many industries, quality is just a basic requirement. Customers assume a particular quality standard and it is usually treated as an afterthought. However, the traditional understanding of quality as mere absence of defects has undergone a major paradigm shift – especially in the pharmaceutical industry.
Given how its products directly impact the human body, the pharma industry considers quality with much deeper significance than other industries. During the production process, pharma manufacturers strive to comply with stringent global regulations and ensure safe and reliable drugs – all this while keeping the production costs at optimum levels.
Components of quality
Quality within the pharma industry is more than just ‘the absence of defects’. Pharma companies look at quality through many components including reviewing processes of quality, regulatory requirements and good manufacturing practices. In order to tackle these challenges, quality is typically broken into several functions such as quality assurance (QA), quality control (QC) and compliance.
The broad scope of QA involves cGMP and regulatory training, documentation, audit, validation and change controls.
QC on the other hand has more to do with equipment handling, lab testing product stability and quality, reports and record maintenance for audits.
Competencies required
The competency requirement essentially depends upon the product line that one is involved with in pharma industry. The educational qualifications needed for a career in quality function of Active Pharmaceutical Ingredient (API) manufacturing requires a strong knowledge of organic chemistry.
Therefore, a BSc or MSc in Chemistry will be the expected educational qualification. On the other hand, the manufacturing of finished dosage forms (often called formulations) requires an in-depth knowledge of pharmacy.
A diploma, B Pharm or M Pharm will be required to take up a job in the quality function of formulations.
While educational qualifications are critical, they serve only as a foundation so that people can understand the basics and use their education to learn more. Professionals will need to learn much more about day-to-day matters such as the nuances in cGMP and regulatory requirements of Food & Drug Administration (FDA) bodies. Quality standards keep on improving so professionals will have to constantly educate themselves in order to know the relevant / current information.
Career outlook
India's pharmaceutical sector is expected to touch US $74 bn in sales by 2020 from the current US$ 11 bn, 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.
In line with the growth of the industry, the demand for professionals will certainly be on the rise. Given the mandatory nature of quality, there will be a promising career opportunity for fresh graduates in the quality function of pharmaceutical industry in the years to come.
In addition, companies are eager to hire students who have strong critical reasoning skills and can understand why certain functions are being followed instead of merely executing everyday tasks.
Growth path of quality professionals
A fresh graduate or post-graduate who joins either QA/QC function will start as an individual contributor assisting in the lab, documentation, record maintenance or coordination across departments. He or she can grow into becoming a team leader managing small teams of five or six people.
As a next milestone, one can aspire to head the QC or QA team at a plant level, which will be a significant managerial responsibility at middle management level. After gaining considerable experience across API and finished dosage manufacturing and also understanding the regulatory requirements of various countries, one can eventually become head of Quality which will be a senior management position.
While this path is a more conventional vertical growth path, cross-functional career paths are becoming more prevalent given the importance of quality. For example, there are individuals who joined in the QC function, moved to the marketing department and ended as the head of manufacturing at the plant level. There are also members who started in quality and regulatory affairs before becoming a business head.
Depending upon the aptitude, 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 will continue to grow and due to the emphasis will likely 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 writer is an HR advisor in a pharmaceutical company.)