Job Description

Sansheng Pharmaceutical plc (SSP) is a GMP certified company by EFDA and is currently working for further international certifications of WHO and other country’s regulatory bodies. SSP is involved in the production of tablets / capsules (annual capacity of 5 billion units) and injection products in the form of ampules (annual capacity of 300 million ampules) and large volume infusions (annual capacity of over 10 million liters/bags) by using fully automatic and semiautomatic state of the art technology. The company also have several expansion plans in to various dosage forms that are going to be erected on its expansion project having more than 16.7 hectare total area of land.

In order to achieve our ambitious goals of making Ethiopia as hub of quality pharmaceuticals in East Africa, we are looking for energetic, enthusiastic, qualified and experienced for the following position.

Duties and responsibility

Under the guidance of the Quality Director, the QA Manager shall carry out the following duties:

• Assures total management and control of Quality Assurance/Quality Control work and personnel.
• Prepares quality assurance plans and procedures when required and ensures their correct implementation to all activities under his control that all documentation and quality control tests are carried out in accordance with approved procedures.
• Releases raw materials, packing materials, intermediate bulk and finished products.
• Release finished products for distribution and sale. Give market authorization to finished products produced.
• Organizes for the development and validation of test methods.
• Lead, advice and supports the implementation of quality assurance systems and procedures for the entire factory.
• Implements and organize initial training as well as continued training of the personnel. Implements and monitors in process testing, GMP inspection and audit of the factory.
• Maintains the department and all equipment and supplies in good order and discipline and high standard of cleanliness concomitant with cleaning procedures and good manufacturing practice.
• Outlines and defines structure of responsibility for quality assurance personnel and workers and pursue constant updating and monitoring for such responsibilities to ensure accurate match to the company’s requirements and targets.
• Plan quarterly and yearly quality assurance programs as well as participates in annual budget preparation in conjunction with the country director.
• Designates and monitors storage condition for materials and products.
• Release finished products to market according the procedures of release for sale & distribution.
• Approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products;
• Ensure that all necessary testing are carried out;
• Approve specifications, sampling instructions, test methods and other Quality
• Control and quality assurance procedures;
• Approve and monitor any contract analysts;
• Ensure that the appropriate validations are done;
• Ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need;
• Use and mobilize resources allocated in his department;
• Participate in the requirement of personals that are going to work in a cGMP facility;
• To carry out department specific planning and executive activities;
• Ensuring compliance with technical or regulatory requirement and other national legislation and international standards as applicable;
• Implementation and when needed establishment of the quality system of the company;
• Monitor the activities of stability study;
• Participation in the development of the company’s quality manual;
• Conformation that the marketing authorization and the manufacturing authorization requirements for the product have been met;
• Conformation that installed manufacturing premises, equipment and testing procedures have been validated and/or qualified;
• Setting QA compliance objectives and ensuring that targets are achieved;
• Ensures that the principles and guidelines of cGMP, as laid down in national guidelines and other applicable international standards have been followed in manufacturing warehousing and quality control;
• Answer queries by the competent authorities under his obligation to collaborate in accordance with national and/or international as far as they related to quality control;
• Supervises and ensures that appropriate audits and self-inspection are carried out by experienced and trained staff in a team;
• Co-operate and co-decide in the approval and monitoring of suppliers and contract manufacturers and to give his agreement for placing orders;
• Follow any planned changes or deviations in manufacturing or quality control have been notified in accordance with a well-defined written system before any implementation and product release;
• Review and approval of a Master Manufacturing and Packaging Record for release of products for sales;
• Review of all QC testing results, production documents, results of in-process control and overall compliance to the specification for the finished product prior to release.
• Review and approval of Qualification & Validation Protocols and reports;
• Ensure that records are taken off all the above mentioned duties and activities and to ensure proper handling of all cGMP records and documents are archived;
• Identifying relevant quality–related training needs and deliver training;
• Ensures that annual product quality review is done as planned and the set procedure;
• Check the maintenance and qualification of the premises, and the maintenance, qualification, validation and calibration of the equipment in his department;
• Check pharmaceutical-technical complaints and product recalls (handling of complaints and returns);
• Monitor and controls raw material packing material and finished product storage conditions;
• Coordinate, direct, monitor and evaluates safety practice and procedures;
• Perform other related activities upon the instruction of Quality Director.

Sex: Males and females

Age: 22-35 years.

Requirements

Education : BSc Degree or More in Pharmacy

Minimum Work Experience required : A minimum of Five Years’ Experience in QA/QC/expert, supervisor or manager.

Skills:

• Good Interpersonal Skill
  Good Communication Skills
  Proactive and commitment for outcome
  Have good practical knowledge about good manufacturing practice(GMP)

Other competences : Special training, Leadership, Teamwork

Submit your CV, copies of relevant documents and Application to:

[email protected]

Use the title of the position as the subject of the email

Closing Date : 7 June. 2024