External Vacancy Announcement

Sansheng Pharmaceutical Plc is GMP certified company for the manufacturing of Solid and Liquid Pharmaceuticals dosage forms in Ethiopia. It is currently under production of large volume parental, small volume injectables, tablets and capsule dosages. Currently Sansheng pharmaceutical plc seeks the following qualified and experienced individuals for Quality Assurance. mentioned below.

Job Summary:

This position supports Quality Assurance department by performing Quality Assurance activities related to change control, compliant handling, annual product review, training, GMP Inspection, validation and others tasks forwarded by the QA Manager.Colleagues in this role should be able to demonstrate the following:

• Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) and Sansheng Pharmaceutical PLC Quality Standards to be a key contributor.
• Identify and implement new processes and programs for quality improvement.
• Contribute to the interpretation of cGMPs for commercial product.
• Decision impact awareness on future quality and compliance as well as impact on own work group, department, and site.
• Independently able to resolve complex issues and represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
• Good judgment and correct decision making based on Sansheng Pharmaceutical PLC procedures, PQSs, technical experience; and industry guidance / regulatory regulations.
• Collaborates and independently engages with a wide range of co-workers, customers and management within to gather the input and background knowledge needed to complete assignments.
• Anticipates issues and elevates them to appropriate management attention immediately.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
• Ability to organize own work to meet project deadlines.
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
• Effective written and verbal communication and interpersonal skills.
• Suggest improvements and conducts continuous improvement activities.
• Interface with and represents Quality Assurance in cross-departmental/cross-site/cross-network meetings, manage working area and projects/changes to accomplish change activities/project deliverables and/or whole projects.

• Responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.

Job responsibilities

• Responsible to ensure change control, compliant handling, annual product review, training, GMP Inspection, validation and others relevant tasks meet all site and regulatory requirements for facilities, equipment and processes.
• Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Sansheng standards, policies and values in a timely manner.
• Initiate, lead working groups and/or manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
• Anticipates issues and elevates them to appropriate management attention immediately.
• Support regulatory audits as needed.
• Provide guidance/coaching to less experienced colleagues.

Total required: One (1) person

Experience:  6 – 8 years relevant work experience in a cGMP(current Good Manufacturing Practices) pharmaceutical manufacturing, testing or Quality Assurance environment.

Requirement: Good English communication and social skill