"This Article would be helpful for freshers, starting there career in Pharmaceutical Industry and to understand what actually the Pharmaceutical Industry is! and how many possible departments are present in a Company"
Basically, Pharmaceutical Company pumps in too much of Infrastructure, Technology, Manpower, huge amount of material management from one's ware house to offshore customers.
And after all this risk pertaining situation, still their is BIGGEST Hurdle that one has to overcome, that is USFDA-Audit.
To, pass swiftly from all this above assessment, the smooth working and amalgamation of all the department is key to success.
Generally, we can divide Pharmaceutical organization in three parts:
A. Corporate Office
B. Research & Development Facility
C. Production Units
All, Functional units or Departments in Pharmaceutical Company can roughly divide in above categories.
We, will discuss above category in brief and definitely have a clear idea regarding all departments.
A. Corporate Office:
Corporate office, is place from where all the actions are planned and monitored. we can say, Corporate office is a functional unit of whole organization.
For the successful business, growth, profit, expansions the department is responsible is Corporate office. For fame of company they are responsible and also for blame they are only responsible.
Department which are active at Corporate are as follows:
- CEO Office: Chief Executive Officer, is the most important person and working force for all organization. He heads and act as a Head of all Departments at Corporate office. His decisions matters a lot, can took to the company name, growth, fame to the height of sky and the same to the depth of bankruptcy.
- Business development: Business development is a department which earns the money for the company. They have to plan to reach the highest point in terms of sales of product as well as monitor the competitors action. Focus on either possible ways of extensive marketing policy and attracting customers and maintaining the healthy relationship in terms of business to keep to rising and growing.
Qualification to Work in Business Development: MBA from Top Management School, Pharma MBA is also preferred, BBA (Bachelor of Business Administration) - Marketing: Marketing works for the sales, promotion of the products in the portfolio. Their work is target oriented within tight timelines.
Qualification: MBA is preferred, Bachelor of Pharmacy, or Diploma in Pharmacy can work in this department. - Accounts: Accounts department responsible for all the payment onshore as well as offshore. As Pharmaceutical market in located all over the globe, accounts deals with all the national as well as international transactions. They also tracks all the taxes, profit and loss for whole year. Qualification: Masters/Bachelor of Commerce, Chartered Accountants.
- Import and Export: Operates for smooth transportation of Products from place to place or country to country.
Qualification: MBA, or Experience in a Field. - Portfolio Management: This Department takes decision for Company Product Portfolio, means which product is to included or should be excluded from Portfolio. We can say they are product forecasting department for company.
Qualification: M.Pharmacy, Business Analytics, One has to perform too much of different analysis. - Licensing: This Department looks after the different Licenses mandatory for Pharma-company as per State and Central Government of India.
Qualification: Any Degree holder with a experience in the field.
B. Research & Development:
Research & Development facility are of different type as per the requirement of company. One can consider the Research & Development facility as a generalized term for different R&D.
First, I will enlist some different type of R&D:
- Formulation R&D: Research regarding different formulation is carried out here.Research limited to Formulation only.
- Analytical R&D: Research is focus and confined to analysis of different samples or products. Analysis by using different analytical instrument like NMR, MASS, DSC, FTIR, HPLC, XRD and TG etc.
- Synthetic R&D: Research is focused on synthetic reactions where, new synthetic routes or new compounds are synthesized.
- Drug-Discovery R&D: From scratch the product development or discovery is started. Different techniques or process are incorporated for outcome of a complex new molecules.
- Clinical R&D: Clinical research is carried on animals or on human subjects. Clinical trials are carried out in this R&D facility.
- Bio analytical R&D: Research is focus on trials of drug on human subject, Evaluate the Molecules for Bio-availability or Bio-equivalence studies.
Different department collaboratively working in R&D:
- R&D department: This R&D may any of the one mentioned in above points.
Qualification: PhD, M.Pharmacy, M. Science, B.Pharmacy, B.Science - QA department: QA assures the quality work done. With the documentary proof for all the workdone. Its one of the major role is facing Audits as well as training for employee.
Qualification: M.Pharmacy (Quality Assurance), M.science - Regulatory Affairs: Role of this department is to carry out different filing to USFDA, EMEA. As, per prescribed format and timelines. They, has to file the (Drug Master Dossier) DMF to USFDA and (Certificate of Suitability) CEP to EMEA europe regarding their products.
Qualification: PhD, M.Pharmacy (Regulatory Affairs) (Pharmaceutics) - Project Management: Responsible for getting workdone by other department within specific mentioned timelines.
Qualification: M.Pharmacy, MBA - Intellectual Property Management: Responsible for patent filing for new inventions and internal R&D support.
Qualification: PhD, M.Pharmacy (Pharmaceutics) (Pharmaceutical chemistry) - Quality Control: They perform the quality check for all raw material as well as finished products.
Qualification: PhD, M.Pharmacy, M.Science - Supply Chain: Maintains and Procures the material as per requirement of R&D.
- Purchase: Responsible for Purchase of all materials at the site.
C. Manufacturing Units:
Manufacturing unit is a place where this valued product is manufactured at specific guidelines required by FDA.
Manufacturing facility may differ from formulation to formulation. Below are different formulation which required different setup for formulation.
- Tablets- Oral solid dosage form
- Capsules
- Pareneterals
- Suspensions, Emulsions
- Metered dosage Forms
- Nutraceuticals etc
Disclaimer: Author is not imitating any organizations or company, the total article is only for information for young professionals in Pharma field.
