Assistant Quality Operations Manager at NFT Consult

Department: Quality Operations

Reports to: Quality Operations Manager

Description of Role

The Assistant Quality Operations Manager is responsible to ensure that all internal and external requirements are met before the product reaches the market and coordinating the activities required to meet these quality standards thus ensuring company efficiency and profitability. The role is responsible for post marketing surveillance of locally distributed products.

The position cooperates Quality Operations Department, Regulatory, Production, Engineering, Warehousing and Supply Chain. 

The main tasks for the position will be:

• Protecting company assets such as equipment, records and premises among others.
• Strict observation of GMP (good manufacturing practices) principles and OSH requirements at workstation at all times and disseminating the same to those assisting/working on equipment.
• Attending all training sessions on cGMP, OSH and continuous process improvements as well as understanding process and job responsibilities.
• Reading, understanding and following standard operating procedures (SOPs) in place for various processes.
• Working closely with the Heads of Quality Operations and Regulatory to ensure compliance with WHO GMP standards.
• Support the Quality Operations Manager during external audits, internal audits and other Quality Management activities like handling of customer complaints, product recalls amongst others.
• Reviewing and approving Batch Manufacturing Records, SOPs, Validaton protocols and other relevant GMP documents.
• Assuring the reliability and consistency of production by checking processes and final output and ensuring all the processes followed comply with the regulatory requirements.
• Review of executed Batch Manufacturing Records and ensuring timely release of FPP for sale to the market.
• Review and approval of annual product quality reviews.
• Review and monitoring of change control requests, deviations, out of specifications, corrective and preventive actions (CAPAs) and conduct effectiveness audit.
• To support the Quality Operations Manager in Market complaints investigation and regulatory investigations.
• Conducting pos tmarketing surveillance of locally distributed products.
• Facilitating proactive solutions by analyzing quality data.
• Monitoring regulatory changes and assessing impact.
• Reporting quality performance indicators at regular intervals.
• Ensuring reachability to Quality Operations Manager in case of absence.
• Any other job as may be instructed from time to time similar to the nature of duties above or as a result of operational necessity.

The ideal Candidate shall have :

• Minimum Bachelor of Science in Pharmacy
• Minimum 3 years in a similar position

Skills required:

• Familiar with WHO GMP
• Must be registered with PPB
• Good understanding of Pharmaceutical Quality Management Systems.
• Ability to work independently.
• Understanding of PPB Framework e.g. post marketing surveillance amongst others.