Deadline: 6th August, 2016 by 5:00 PM
Duty Station: Kampala, Uganda
Reports to: Assistant Production Manager
Abacus Parenteral Drugs Limited is one of the largest sterile injectable pharmaceutical companies in East Africa, with a market presence in Tanzania, Kenya, South Sudan, DR Congo, Burundi and Rwanda. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are used predominantly in the treatment of critical illnesses. Our product range also includes various therapeutic segments, including ophthalmology, optic and nasal. We offer eye, ear and nasal drops in plastic bottles of 10ml. We also offer our intravenous infusion range with Nipple Head, produced by BFS Technology.
Key Duties and Responsibilities:
Related to Dispensing:
- To fill the Batch Register upon receipt of production plan and send it to QC department for BMR preparation.
- Get BMR approved by the Production Manager and Quality Assurance Manager and in their absence the Assistant Production Manager.
- Take the Store Requisition Slip (SRS) from the BMR and get the authorized signatures.
- Make the required equipment available in advance which is necessary for dispensing like sterilized scoops, double plastic bags, and cable ties.
- Give the proper identification tags on issued material in dispensing area.
- Weigh and issue correct quantity of material and balance calibration in dispensing area.
- Keenly monitor positive pressure and temperature/Humidity of dispensing area, bottle unloading and sterile wash area and inform engineering services department, if any abnormality found.
- Regularly check the cleaning of dispensing booths, scoops etc after dispensing is over.
- Return excess raw and packing material after completion of dispensing to store using a return slip.
Related in Clean Room Maintenance:
- Monitoring of temperature/Humidity of clean rooms of manufacturing areas and if deviated from defined area, inform to engineering services department and shift in-charge.
- Supervise the cleaning and disinfection of floor, ceiling, wall, pipeline vessels and equipment as per the frequency defined in standard operating procedure.
- Report to shift in –charge, executive production and engineering services department regarding any kind of maintenance work of clean room through work request form.
- Regularly check cleanliness of air locks after entry exit of the workers.
- Ensure availability of sufficient numbers of garments in the clean room through follow up with sterilizer and dispensing chemists.
- Regularly check and supervise proper growing of workers.
Related to Batch Manufacturing:
- To have knowledge of each and every stage of batch manufacturing as per validation study.
- Ensure cleaning and steaming process is carried out as per validated procedure.
- Get the okay from quality control WFL approval/batch manufacturing/filtration /zero sampling.
- BPT/FFT of production filters before and after filtration.
- Regularly check the Wit of air filter.
- Acquire knowledge regarding operation of all equipments of clean room.
- Follow up of SOP during manufacturing of batch.
- As an administrator in the manufacturing area he is responsible to manufacture the goods complying all GMP standards.
- Ensure and check the health standards of persons working in the clean room area.
- The incumbent will stop the production if the quality standards and GMP standards are compromised.
Related to Filling:
- Checking ALF pressure before 30 min .of starting of operation.
- Volume setting and volume checking at regular time interval.
- Continuous checking of percentage Oxygen content in bottle.
Related to Sterilization:
- Ensure the availability of empty trolleys for the next shift.
- Put status tags on every trolley before and after sterilization.
- Plan sterilization of products appropriately in case more than one products are in production.
- Co-ordinate with Utility Department before running any sterilization cycle.
- Regularly monitor the sterilization process Production Manager and Maintenance Department using a work request form in case of any abnormality or corrective action.
- Transfer of unloaded finished product in respective G.Q. area.
- Inform and prepare intimation for finished product sample to QC department.
- Ensure the sterilization of garments and their arrangement in the respective clean rooms as required.
- Ensure the minimum wastage of utilities like steam, cooling water,compressed air, electricity etc.
Related to RODM & WFI Plant:
- Ensure smooth functioning of RODM plant and inform Engineering department using a work request form for corrective action if required.
- Provide support during Regeneration of the DM plant.
- To have thorough knowledge of SOPs of own working area and to ensure its implementation.
- Coordinate efficiently with other colleagues of the department.
Related to Documentation: Fill up and sign various records including:
- Sterilization records for Superheated Water Spray and Auto-sliding Door sterilizers.
- Floor cleaning record for Pre- and Post-sterilization and sterile wash room areas.
- Positive pressure records
- Temperature /Humidity records
- Balance calibration records
- Garment sterilization record
- Batch Register
- BMR-Raw material dispensing records
- BMR packing records
- BMR-Sterilization records
- BMR-Reconciliation records
- Finished product intimation book
- While filling up the records they will take precautions like;
- Clear and legible writings.
- No over writings.
- If any mistake occurs, strike it once and countersign.
Qualifications, Skills and Experience:
- The Production Chemist should preferably be a Fresh graduate with a Bachelor’s degree in Chemistry, Biology, Pharmacy or related field or possess one to two years of experience in pharmaceutical or health care industry.
- Good supervisory skills
- Computer literacy in Word, PowerPoint and Excel
- Good verbal and written communication skills
- High integrity and attention to detail
- Good team player
How to Apply:
All suitably qualified and interested candidates should send their applicationsand updated CVs to:
The Human Resource Manager,
Kiboko Group of Companies,
Location: Plot Nos. 28B, 32B, 34B, UMA Show Grounds, Lugogo
Postal: P.O. Box 31376, Kampala, Uganda