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. Given how its products directly impact the human body, the pharma industry considers quality with far greater significance. Pharma companies look at quality through many components including reviewing processes quality, regulatory requirements and good manufacturing practices. To tackle these challenges, quality is broken into functions including quality assurance (QA), quality control (QC) and compliance.
The broad scope of QA involves cGMP and regulatory training, documentation, validation and change controls. QA is related to process compliance and is oriented towards documentation. This allows external agencies to inspect the facility. Here documentation becomes important. What needs to be documented is decided by the QA.
QC has to do with equipment handling, lab testing, reports and record maintenance for audits. QC involves direct monitoring of the product. This means taking samples of the product and testing it for impurities. In case there is any kind of problem during the test with the QC with the batch, it is stopped and an investigation is done.
The competency requirement 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. So, a BSc or MSc is the expected qualification. And the manufacturing of finished dosage forms (often termed as formulations) requires knowledge of pharmacy. A diploma, BPharmacy or MPharmacy is required to take up a job in the quality function of formulations.
While qualifications are critical, they serve only as a base. Professionals need to learn much more about day-to-day matters such as the nuances in cGMP and regulatory requirements of FDA bodies.
Indias pharma sector is expected to touch $74 billion in sales by 2020 from the current $11 billion, according to a PwC report. In addition, India is a large manufacturing hub for MNCs. In line with the growth of the industry, the demand for professionals will only rise. Given the mandatory nature of quality, there is a promising career opportunity for fresh graduates. Companies are also eager to hire students who have strong critical reasoning skills and can understand why certain functions are being followed.
A graduate who joins QA/QC functions starts as a contributor assisting in the lab, documentation, record maintenance or coordination. He or she can grow into becoming a team leader. Then one can grow to head the QC or QA team at a plant level which is a managerial responsibility. After gaining experience across API and finished dosage manufacturing and also understanding the regulatory requirements of various countries, one can become the head of quality. Quality standards are becoming more stringent that will force companies to inspect their quality systems. Thus, the demand for professionals in quality functions will continue to grow in the future.
The author is a strategic advisor at Granules India. Views are personal