Title:  Quality Assurance Senior Supervisor

Job Purpose:

To lead and supervise quality operations team for both sterile and non sterile plants to ensure quality by design during different in process steps during manufacturing, maintaining high quality level and quality culture in the work environment.

Duties & Responsibilities:

• Recommend 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 Assurance department to ensure that work processes are implemented as designed and comply with established policies, processes and procedures.
• Reviews and approves documents generated by the department, in order to provide approvals on deviations, CAPA, and annual product review reports.
• Participates in quality risk management procedures, in order to manage and maintain the day-to-day change control process for product and process related information.
• Supervises the creation and revision of batch record documents to support product development and product implementation.
• Participates in developing divisional procedures and guidelines to develop responses to corporate, regulatory, and third-party audits findings
• Utilizes data from QA Trending for Complaints, Deviations, CAPA, and Risk Assessment to identify and escalate Product Quality risk and monitor QA metrics as appropriate.
• Reviews and investigates specific cases for quality issues at the supplier site during audits to support Hikma Quality units
• Conducts gap analysis for Hikma functions actual and potential performance to facilitate harmonizing the system within the group.
• Organizes and supervises the activities to ensure that all work within a specific area of Quality activity is carried out in an efficient and procedurally compliant manner
• Complies with all relevant safety, quality and environmental management policies, procedures and controls to ensure a healthy and safe work environment.
• Supervise and control batch release team to ensure effective batch records review according to the relevant procedure and all batches are released according to the relevant procedures meeting required shipping plans.
• Complete oversite and leadership for the IPC team for all sterile and non-sterile plants, dealing and taking appropriate decisions for all trouble shooting and incident situations.

Qualifications:

• Bachelor’s degree in pharmacy or relevant.
•  At least 8 years of experience in the pharmaceutical industry.
• Excellent organizational and leadership skills
• Sterile Pharmaceutical background is a must.
• In depth understanding of Quality Assurance procedures
• Job Location: Bady City