Quality is more than mere absence of defects. An expanding drug industry needs professionals who understand the changing demands of the quality control process.
Healthcare is a basic human need. There is always a scope to innovate, discover and improve the availability of medicines for various ailments. The global pharmaceutical industry is expected to grow at a 3 – 6 per cent compound annual growth rate (CAGR) over the next five years. The focus is on addressing unmet medical needs, making medicines more affordable and optimising manufacturing processes.
The industry is growing steadily throughout the world and particularly fast in markets such as India. Due to this rapid advancement, the demand for professionals will continue to rise.
The traditional understanding of quality as mere absence of defects has undergone a paradigm shift. Given that pharma products directly impact the human body, quality has much more significance here than in other industries. During the production process, the manufacturers strive to comply with global regulations and ensure safe and reliable drugs — all this while keeping the production costs at optimum levels. Pharma companies look at many sides to quality through many components including reviewing processes, 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. Quality assurance is related to process compliance and heavily oriented towards documentation. This allows for inspection of the facility by external agencies inspect the facility. 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 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 and so on. In case there is any kind of problem during the QC test with the batch, it is stopped or reprocessed and an investigation is done.
The competency requirement essentially depends upon the product line that one is involved within the pharma industry. A career in the 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 finished dosage forms (often termed ‘formulations’) will require knowledge of pharmacy. A diploma in pharma, B.Pharm. or M.Pharm. will be required for taking up a job in the quality function of formulations.
While educational qualifications are critical, they serve only as a base. Professionals will need to learn much more about the day-to-day matters such as the nuances in cGMP and regulatory requirements of Food and Drug Administration (FDA) bodies. Quality standards keep on improving and professionals will have to constantly keep themselves updated.
In line with the growth of the industry, the demand for professionals will 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.
Career outlook and growth path
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/she can grow into a team leader managing small teams of five or six people. As a next milestone, one can aspire to grow to head the QC or QA team at a plant level which will be a significant managerial responsibility at the 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.
Quality is a dynamic field and will challenge professionals due to its ever changing nature. The demand for professionals in quality functions will continue to grow and will likely grow faster than the overall industry.
The writer is HR Advisor, Granules India.