Who is Manufacturing Chemist? Definition, Job Responsibilities, Qualification etc.

Manufacturing Chemist:
A Manufacturing chemist is a person who look after complete manufacturing process in a pharmaceutical manufacturing unit. Manufacturing chemist is top most technical staff who is directly responsible for all activities and processes during a batch manufacturing. He is responsible for sustain manufacturing process and quality product manufacturing. Manufacturing Chemist is a signatory officer. Without manufacturing chemist signature, a manufacturing batch can’t be dispatched to stock room.
How can we define Manufacturing Chemist?
A Manufacturing Chemist is defined as an authorized person to conduct, perform and initiate all procedure related to pharmaceutical products manufacturing. Manufacturing Chemist is also known as Production Chemist. Manufacturing Chemist has responsibility to define and instruct factory workers and supervisors about production process to ensure that the manufacturing procedure should comply with required standards ,and quality, efficacy and sustainability of product could be maintained.

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Job responsibilities of Manufacturing Chemist:
  • Lead a team for carrying out activity related to manufacturing procedure
  • Directing workers and Supervisors regarding manufacturing processes.
  • Coordinating with QA and QC team for quality production
  • Technical Support on the manufacturing processes, machine operation, record maintenance 
  • Follow Master Formula Record and maintaining sustain product manufacturing
  • To work in GMP environment by following procedure/production operations as per SOPs.
  • Comply to the regulatory requirements at each stage of activity
  • Maintaining Manufacturing Records and documentation
Query:
Sir can you please provide me the information regarding the qualification needed to open the pharma production unit as i went through your comments you have wrote registered pharmacist under state council. But sir I want to know whether bachelor degree is sufficient or one have to do masters for it.



Response:

For production unit, Manufacturing chemist requirement is necessary. For Pharma marketing company registered pharmacist is enough. A person can be registered pharmacist if he/she has Diploma, degree or higher Pharmacy education. But registered pharmacist qualification is not enough for pharma production unit. You have to be a manufacturing chemist approval.

Minimum qualification for manufacturing chemist is as follow:
B.Pharma with minimum of one and half year experience in pharmaceutical product manufacturing
Or
B.Sc. with minimum of three year experience in pharmaceutical product manufacturing.

Hope this information is helpful to you…

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