Md Abu Taher

Executive at Incepta Pharmaceuticalslimited

• Bangladesh
• January 2014 to October 2016

Duties & Responsibilities:
• Microbiological analysis of raw materials, bulk products and finished products, Sterility test, Endotoxin test, Regular analysis of portable water, purified water and water for injection (WFI), Microbial limit test, Bioassay of products, Maintenance of microbial culture, Preservative efficacy test, Regular microbial culturing, Antibiogram test.
• Handling and execution of Quality Management related activities (Quality Assurance Module) in SAP system.
• Handling Deviation, Change Control, Out of specification (OOS), material rejection report (MRR) and corrective and preventive actions (CAPA) reports.
• Prepare annual product review (APQR) report.
• Regular inspection of the plant, to ensure that good house-keeping and approved procedures are being practiced to ensure that it meets the standards of cGMP at all times.
• Where necessary to make recommendations to improve the overall efficiency and appearance of the plant to ensure that it meets the cGMP.
• Generating all the required documents for production i.e. Batch Manufacturing Record (BMR), Batch Packing Record (BPR) and SOPs.
• Performing the compliance operations in production area by giving line clearance, performing in-process checks, sampling bulk material, finished product and retention sample as and when required.
• Generating and implementing all GMP related SOPs.
• Compilation of Batch History which includes BMR, BPR and other relevant documents as well as releasing the product.
• Maintaining records and relevant documents of reworked products.
• Handle of product complaints, product recalls and returned goods as per standard departmental procedures.
• Organizing and performing the self inspection and also to and submit report on findings to receptive authority and to take part in to the follow up action.
• Ensuring all log books for raw data, records & documentation are properly maintained and checked, calibrations of automated equipments, reagents and thermometers are properly maintained in regular intervals.