Job description

Job Purpose:

To manage activities related to the quality control unit within the quality department including management of tests in products analysis, overseeing procedures, training direct reports, allocating workloads and troubleshooting any problems in order to detect any defects or issues in products before they are released into the market. 

Duties & Responsibilities:

• Recommends improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Quality activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost- effective service to customers
• Supervises the day-to-day operations of Quality section to ensure that work processes are implemented as designed and comply with established policies, processes and procedures
• Manages laboratory activities for assigned functions and projects to create short- and long-term work plans, assignments and milestones for direct reports. 
• Supervises training activities for their teams to ensure they have the proper tools to achieve the identified objectives, maximize their potential and improve their individual effectiveness in meeting business needs. 
• Manages the support for other departments in executing investigations and preparing deficiency letter responses to ensure efficient registration process for Hikma products. 
• Supports activities related to analytical method transfers for the assigned projects to ensure efficient transfer of projects between sites. 
• Reviews technical documents, including validation protocols and reports, reference standard qualifications protocols/ reports, analytical test procedures, Certificates of Analysis; technical reports, change controls and investigations report to ensure the documents are up to standards and comply with regulations. 
• Standardizes processes throughout the laboratory to ensure compliance to cGMP’s and current SOP’s. 
• Participates in the management of analytical procedure development and reviewal to ensure that they conform to current and appropriate scientific, compendial and regulatory standards and are suitable for use for their intended purpose.
• Develops and implements procedures, systems and training activities to develop an appropriate level of scientific expertise within laboratory to ensure the successful execution of project work to current pharmaceutical industry technical standards and to maintain compliance with cGMP’s.
• Manages troubleshooting activities for any potential faced issues to ensure keeping records of such issues and finding the best solution to solve them
• Prepares departmental reports of quality timely and accurately to meet company and department requirements, policies and standards
• Job Location: Beni Swief City

Qualifications:

• Bachelor’s degree in pharmacy.
• Minimum 11 years of experience in pharmaceutical industry.
• Excellent leadership, communication, and problem-solving skills.
• Excellent organizational and leadership skills
• Sterile Pharmaceutical background is a must.
• In depth understanding of Quality Control procedures and relevant legal standards.