Qualified Persons in Pharma Industry

Sometimes, for a moment when your attention over a production line flips, there could be a blunder, disaster or loss. 

I remember well the grief-stricken story of an employee, who was newly appointed in one reputed pharma company. While on work, at the conveyor belt, she accidentally got her finger stuck in the wheel. 

With pain, she shouted and started crying. Immediately, the assembly line was stopped.

“O my finger,” she said as she saw blood flowing profusely.

And next moment, she was left in panic as she saw part below the nail of her index finger was totally chopped. Only the nail was dangling. Her colleagues desperately looked over the production belt and searched the surrounding area for the missing piece of flesh. Luckily, it was found, but all frozen and pale.

She was rushed to the hospital, but the severed piece was of no use because it was all dead. And, to avoid malfunctioning of her finger, immediate decision was taken to perform plastic surgery.

Over the period, after that successful surgery, she gained her finger’s functionality, but there’s a scar on her finger and whenever she remembers that incident it jolts her heart with grief.

Unfortunately, production fallacies happen in pharma industry due to human error or machine error causing production loss, fatal accidents or safety hazards. That’s awful and disheartening.
Sometimes, for speedy production and faster revenues, there could be possibilities of errors. And when errors happen, the whole production batch gets lost.

The more your staff is illiterate, unqualified to comply with procedural and safety standards,  there’s more possibilities of human error, besides machine error due to inability to operate well.

Perhaps, more than any industry, there’s more talk about pharma industry in terms of safety, quality and efficacy of the products. It’s not only that a pharma company has to be certified, with updated facilities, warehouses and documentation procedures, but what matters most is the qualified manpower.

In fact, a pharma company’s focus should be on patients’ health, safety and well-being. With this core priority, it’s must for a pharma company to have high quality and production standards, systematic processes and qualified workforce. 

From top to bottom…everyone has to be relevantly qualified based on their positions and nature of jobs. Be it packaging supervisor or labeling operator, be it production inspector or lab technician, be it product assembler or warehouse worker or be it process supervisor or machine operator. 

And, one compulsory criteria that cannot be ignored is minimal reading proficiency in English where often production labors are involved in printed material handling.

In particular, some pharma companies are too rigid when it comes to recruiting qualified personnel. Along with essential qualifications, it matters what experience and knowledge one holds to perform job duties. With this planned approach, no doubt, employees can demonstrate ability to follow instructions, work schedules, product inspection techniques and adapt to changes based on the company departmental demands. 

The other advantage is that employees can work independently during certification process and possible production activities. The good thing is that there will be minimal mistakes and supervision when the whole environment is in compliance to respective standards.

What if you don’t hire qualified employees? That’s a BIG question! Well, in order to maintain hassles-free planning, coordination and control of manufacturing processes and smooth logistics operations, there’s an extra burden on the management to provide training modules and guidance to all the employees, at different levels in order to maintain a safe and clean work environment while complying with all cGMPs and SOPs.

Some companies think it’s a smart way to hire menial production labor, and slot few classroom sessions to train them. That’s not cost effective strategy. 

In fact, that’s a tedious task to identify training needs and eventually leading to time-consuming activities, extended roles to monitor and motivate workers and lowering production efficiencies.

Image source: pharmamanufacturing.com