Medsol Pharmaceuticals Head, Quality Assurance and Quality Control Jobs in Ethiopia

Medsol Pharmaceuticals Head, Quality Assurance and Quality Control Jobs in Ethiopia


Job Id: 221281

Category: Pharmaceutical

Location: Addis Ababa

Career Level: Senior Level (5+ years experience)

Salary:

Job Description

MedSol Pharmaceuticals, a well-established manufacturer of intravenous (IV) solutions for parenteral administration in humans, located in Addis Ababa, is seeking to recruit for Head, Quality Assurance and Quality Control position:

Purpose of the job

The Quality Assurance/Quality Control Division has responsibility for managing key elements of the Quality Management System (QMS) and monitoring its effectiveness.

It, amongst other things, conducts self-inspections, initiates and follows up on corrective action and preventive actions and reviews and approves quality critical changes.

The Division is also responsible for the control and issue of all Standard Operating Procedures, maintenance of the Site Master File, maintenance of the Site Validation Master Plan and the review/approval of validation documentation.

Further, the Division is responsible for the maintenance and ongoing improvement of the Quality Management System and ensures that all Ethiopian Food and Drug Administration (EFDA) regulatory requirements and other government regulations are met at all times.

The Division is the primary contact during regulatory inspections and customer audits.

Specific duties

The successful candidate will be responsible for:

  • Writing investigation reports and initiating/following up on corrective and preventative actions;
  • Promoting continuous improvement of the Quality Management System, including cGMP compliance;
  • Overseeing the development and implementation of all or some of the company's Standard Operating Procedures (SOPs);
  • Leading /managing the work of laboratory analysts, in this position, ensuring workforce planning, coaching of subordinates, retention and performance management;
  • Providing QA/QC and compliance oversight of suppliers and vendors;
  • Conducting self inspections and external audits as appropriate;
  • Supporting quality related customer complaint investigations and trending activities;
  • Developing and implementing improved quality reporting measures;
  • Approving pre and post execution validation documents;
  • Providing training in all aspects of Quality Management Systems and GMP including procedural updates;
  • Generating of product quality reviews and providing support and advice during investigations as may be required;
  • Generating Technical Agreements and Summary of Finished Product Specifications as appropriate;
  • Reviewing all batch related documentation;
    Representing the company, as may be required, at meetings and conferences.


    Job Requirements

    Requirements

  • B.Pharm with five years' post graduation experience or M.Sc. in Pharmaceutical Chemistry/Pharmaceutics/ at least two year's post-graduation experience.
  • At least five years of relevant professional experience in quality assurance and quality control in the pharmaceutical industry;
  • Deep understanding of aseptic manufacturing process;
  • In-depth knowledge of cGMP and applicable national and international regulations and guidelines;
  • Knowledge of Ethiopian quality related pharmaceutical regulations as well as expert understanding of WHO guidance on pharmaceuticals manufacturing;
  • Knowledge, skills and experience required to provide leadership to the Quality Assurance/Quality Control functions as they relate to GMP facilities, manufacturing, training, auditing, and testing;
  • Experience of conducting quality based investigations and root cause analysis;
  • Experience of conducting self-inspections and of product quality review requirements;
  • Understanding and experience of change control and change management;
  • Good communication skills; competent writing skills, good IT and quantitative skills;
  • Innovative thinker committed to the values of integrity, diligence, client orientation, professionalism, accountability, transparency, and scientific rigor.
  • Membership of professional associations will be an asset.

    Conditions of service

    Medsol Pharmaceuticals offers attractive conditions of employment in a competitive setting. Salaries and wages depend on experience.

    How to Apply

    Individuals interested in applying for the advertised positions may submit their applications and detailed curriculum vitae (CV) in English to medsolpharm@gmail.com and/or to

    Medsol Pharmaceuticals PLC

    P. O. Box 25882 Code 1000

    Addis Ababa, Ethiopia

    within two weeks from the day of posting of this notice to and no later than 10 Sept 2019. Late applications will not be accepted. Successful candidates will be expected to assume duties as soon as possible. Medsol is an equal opportunity employer.

    Female candidates and academics/researchers seeking to get industry experience are especially encouraged to apply. Only short-listed candidates will be contacted for interview and/or technical examination.

    Medsol Pharmaceuticals Head, Quality Assurance and Quality Control Jobs in Ethiopia

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