NEW ROLES IN PHARMA
Changes in regulations, audits and market demand are leading to an increase in exciting new job opportunities within pharmaceutical companies
The global pharmaceutical industry is valued at more than $ 960 bn ( IMS Health Market Prognosis, June 2013) and is expected to grow at a 5.3 per cent for the next five years. While the industry will grow at a steady pace, it will also witness an increased focus on compliance and manufacturing.
Quality standards are increasing throughout the world including in semi- regulated markets. In addition to higher quality requirements, companies are also pushing manufacturers to offer lower prices. This increased pressure means Pharma companies will need to reassess their priorities which means certain career paths in Pharma will see a strong growth in the future.
Over the past year, Indian pharma has experienced a slew of product recalls, warning letters and import alerts from regulatory agencies. Regulatory bodies will follow the U. S.
FDA’s lead by increasing staff presence in India which will result in more surprise audits. This increased scrutiny means the industry will ramp- up investments to ensure compliance.
Pharma companies look at compliance through several components including regulatory requirements, and good manufacturing practices. In order to tackle these challenges, compliance is broken into several functions such as quality assurance ( QA), quality control ( QC) and regulatory affairs ( RA).
While officials will focus on compliance, RA and QA will also be critical as companies increase their regulatory filings. Western- based companies are looking to lower costs by outsourcing to a more cost- effective manufacturing base such as India. Companies will want to have strong RA departments so they can quickly seize new opportunities including technology transfer projects. The increasingly complex world of regulation means that companies are always on the prowl for individuals with solid regulatory knowledge and the ability to interact with regulatory agencies.
While quality standards are increasing, customers are concurrently demanding lower prices. Successful companies will be able to offer lower prices by focusing on improving manu- facturing efficiency through process innovation. The industry will begin to look at operational excellence as a strategic growth tool.
For example, when a manufacturer produces billions of tablets, a 0.1 per cent increase in the production yield will result in major cost savings. People in Operational Excellence ( OE) usually come from a chemical engineering background and work in teams dedicated to process improvement. OE roles are highly collaborative because the team has to understand the impact of any changes including regulatory and quality aspects. Within the Pharma industry, OE is still in its infancy but it will become a critical department as companies are forced to control costs.
The Indian Pharma industry will continue to offer compelling careers to forward- thinking professionals. Employees will have an opportunity to work in a dynamic environment that is constantly evolving. Given the increasing complexities within the industry, successful employees will need to go beyond providing standard solutions and will need to think differently so they can offer innovative solutions that give their companies an advantage.
A technician monitoring crystallizers at Paracetamol API Facility, Bonthapally