Manger Quality Control For Kampala Uganda Plant

Role & responsibilities

• To plan & organize the testing of RM / PM / FG in process samples in compliance with approved procedures / GLP and applicable regulatory requirements.
• To monitor compliance with cGLP and cGMP requirements in the laboratory.
• To approve or reject, as seen fit, starting materials, packaging materials and intermediate, bulk and finished products in relation to their specifications.
• To ensure that all necessary testing are performed & associated records evaluated.
• To approve specification, sampling instructions, test methods and other Quality Control procedures.
• To approve and monitor any analysis carried out under contract.
• To ensure the qualification and maintenance of department, premises and equipment.
• To ensure that the appropriate validations are done including those of analytical procedures & calibration of control of equipment are carried out.
• To oversee the control of reference and retention sample of Material.
• To ensure the correct labelling of Material and Products.
• To ensure that all QC operations are carried out in accordance with written procedures and, where necessary, recorded.
• To ensure the monitoring of the Stability of the Product.
• To assist in process validation and cleaning validation activity.
• To ensure that the required initial and continual training of department personnel is carried out and adopted according to need.
• To participate and conduct training program in general for all plant personnel.
• To carry out inspection, investigation, and withdrawing of samples, in order to monitor factors that may affect product quality. This will be done for market complaints, product recall , out of specification, incident etc.
• To plan the testing of pre shipment samples during approval and monitoring of suppliers.
• Retention of records.
• To participate in management review process performance, product quality and QMS for continual improvement.
• To carry out internal audit in cross functional departments
• To represent the departments as an auditee in audits/ inspections.
• To perform and participate in Self-inspection as per the schedule and verify the compliance.
• To participate in external audit i.e. vendor audit, Contract Laboratory and in validation programs.
• To perform manual integration as per requirement and justification.
• To participate in QRM programme.
• To participate in Environment monitoring programme and control of manufacturing environment.
• To perform the periodic review of electronic data and user privileges in QC department.
• To ensure that the quality of the pharmaceutical products are fit for their intended use, comply with the requirements of the license and do not place patients at risk due to inadequate safety , quality or efficacy.