Discover the most common departments that make up a BioPharma company, learn about the responsibilities of each department and figure out which role is the right fit for you.
The pharmaceutical industry is vast, and if you’re looking to start your career in this industry, it can be difficult to choose which department is the best fit for you.
Understanding the various departments beforehand can be a great help when deciding where to apply, and it can give you a clear idea of what you’ll be expected to do on the job.
Naturally, you’ll be looking for a role where there are plenty of benefits without too much grueling work. You’ll have to remember that everyone has different preferences and expertise, so what’s challenging for you may be ideal for someone else.
Here are some of the central departments that make up a pharmaceutical company that you can consider in your job search.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a system that ensures that all the products being produced are consistent with quality standards. The goal is to minimize the risks involved in pharmaceutical production, as it is difficult to make any changes once the product goes through testing.
The GMP department covers all aspects of production, from starting materials and equipment to the training and hygiene of the staff. Detailed written procedures are provided for each process. The documented proof is needed to showcase that the correct procedures were followed at each step of the manufacturing process.
The instructions and procedures must be written clearly. The operators are trained so that the records can be adequately maintained during manufacturing.
GMP regulations act as a good business tool that keeps compliance and performance up to optimum levels and has a quality approach for continuous improvement. Relevant departments under any pharma company will have to train their personnel for GMP and other necessary standards.
Regulatory Affairs
A professional in the regulatory affairs department strives to make sure the company remains compliant with mandated regulatory standards throughout each stage of development.
Stephen Amato, department chair for regulatory affairs, quality assurance, and advance manufacturing at Northeastern University in Boston, helps define the role of someone in this department.
In an interview with ASBMB Today, he said, “At its simplest, regulatory affairs is about keeping people safe.”
Simply put, the role of a regulatory affairs specialist is to analyze new and existing regulations that have to do with the pharma company’s operational processes, its products and the technologies it is planning to license.
They have to keep an eye on how the drugs and medical products are being developed, tested, manufactured, marketed, and distributed. At the same time, they also aid companies and become the liaison between the regulatory agencies to help make sure that the required regulations are being met.
Research and Development
One of the most critical stages in drug development in any biopharma company is the research and development (R&D) process. The responsibilities of those working in this sector are vital to produce a successful end product.
The process involves an initial candidate drug being identified and then going through multiple research tests to determine its quality and stability. Employees assess the affinity for the biological target and interaction with biological systems and conduct relevant research to support their findings.
In the R&D department, there is plenty of collaboration involved with other disciplines related to biological sciences. Standard research positions that you can opt for include in vitro and in vivo testing of drug candidates, including pharmacology, immunology, molecular biology, virology, microbiology, cell biology and neuroscience.
Quality Control
The work of the quality control departments in pharma industries is serious business. This sector makes sure that trust is built, reputational risk is reduced and operational efficiency is at its best.
In other words, the quality control department ensures the quality of all the products manufactured at every stage of production.
They carry out sampling, inspection and testing according to the specifications, which then are confirmed for release or rejection. The Quality Control department is also responsible for further processing or reprocessing of the product, as well as its documentation.
The five main objectives you will have to keep in mind while working here include:
- Protect the Public
Public safety will always be at the forefront when working in this sector, since you create medicines that can adversely affect the individual if something goes wrong.
Strict quality control processes have to be applied, and some of this includes document control, employee training, deviation, corrective and preventive action (CAPA), internal audits, management review and laboratory OOS (Out of Spec).
- Maintain consumer confidence
Despite the pharma industry existing for the sake of saving lives and curing diseases, some people are wary of the industry.
To keep a reliable image of the company, you have to keep certain actions in mind. As an employee belonging to the quality control sector, you will have to learn from your country’s pharmaceutical research and manufacturers sectors and take the initiative to talk about the innovations and hard work that goes into creating various drugs and medicines.
Quality Control departments also aim to open communications and take a more proactive role in the discussion of distribution and pricing.
- Improve production efficiency
Just like any other business, one of your primary responsibilities is going to be constantly finding new ways to reduce costs, add value and find competitive advantages in the long run.
But how can you and your team be innovative with efficiency practices while still upholding the strict requirements of quality assurance?
Some ideas include automating your processes, interfacing with your disparate systems and collecting data wherever possible. Basically, take advantage of advanced technology as much as you can.
Production
The production department in a pharma company is responsible for manufacturing processes, and this extends to quality aspects. As a production professional, you will have to have up-to-date knowledge about quality systems and a solid idea of manufacturing operations.
Both must comply with GMP, quality, safety and environmental regulations. Moreover, you have to make sure that all product delivery schedules are in order and well-coordinated with the API Research team, quality assurance, quality control, engineering and warehouse teams.
The production team also works toward regularly supporting and maintaining equipment, systems and procedures related to manufacturing operations.
Final Takeaway
The information mentioned above only scratches the surface of the various departments that make up a pharma company, so if you’re wondering which department is best in the pharma industry, that would depend on which sector resonates with you the most.
One thing’s for sure: whether you work in the pharma hr department, production, marketing or research, you will play a vital role in the creation and distribution of life-saving drugs and medicines.
