Job Description For IPC
Inspection on the dispensing process.
• Inspection on the division of the ware house the release area, guarantee area and the
reject area with the true identification labels.
• Follow up the check list of the RH, Temp. at the different places at the ware house.
• Inspection on the destruction process for the rejected finished products, raw materials
and packaging materials.
• Inspection on the raw and packaging materials and ensure its comply with the
acceptance criteria.
• Inspection on the gowning according to the SOP.
• Inspection on the preparation process including check the weight of the raw materials,
changing the filters, the CIP process and the SIP process.
• Inspection on the autoclave activities with different sterilization programs.
• Inspection on the filling process at the filling room and ensure that the area is clean
from any previous product and that the machine is cleaned and sterilized for the new
product.
• Check the environmental monitoring for the sterile area.
• Check the RH, the temp. And the p of all the sterile area according to its classification.
• Check the weight, the shape and the sealing of the filled bottles.
• Inspection on every process according to the batch record and ensure that the line
clearance process are completed between every product.
• Taking the samples to the Q.C department as the bulk sample: for ph. and assay, bio
burden for microbiology.
• Taking the samples to the Q.C department as S.F.P. sample: for finished analysis and
sterility analysis.
• Review the recording of all the production steps at the batch process and the batch
packaging.
• Release the batch to the guarantee area after the final reconciliation by the yellow label,
then by the green label after the certificate of the chemical and microbiological analysis.
• Include recording all the deviation which occurs at all the production process and
writing the corrective and preventive action.
• Recording any complain from any customer from any product and investigate about the
reason of the problem and solving it.
• Making internal audit on all the departments of the factory and recording the points
which deviate from the right process and informing each department by its point to
follow up this points and solving it then inform the QA by the corrective action which
they did.
Job Description for QA inspector
To Create Quality System according to Pharmaceutical GMP regulations y means of SOPs, SMP,
QMP, CMP plan, organize, and supervise the activities of auditing, in-process inspection in
manufacturing and packaging, and quality assurance administration to ensure regulatory
compliance and maintain proper documentation of quality system.
Essential Duties and Responsibilities:
1) Comprehend, maintain, and promote cGMP and SOP compliance as per SFDA regulated
manufacturing environment, ensuring product integrity, safety, and compliance with standards.
2) Plan and supervise the daily activities of the quality assurance operation and inspectors, to
ensure work is completed in a timely and accurate manner.
3) Be proficient in all areas of manufacturing and packaging inspection process, including inprocess QA, line inspection, label cage operation, incoming inspection, and expiration date
assignment. Perform these duties as needed and directed by QA Management.
4) Review batch records for accuracy and completeness for product disposition. Ensure that
corrections are made in a timely manner.
5) Write Exception reports and provide information needed to investigate, document, and close
Exceptions. Participate in non-compliance and customer complaint investigations.
6) Create and revise SOPs and Work Instructions. Track and trend metrics.
7) Perform other duties as required.