Quality Management System (QMS) Manager.

Location: Dawa Limited- Ruaraka

The Position: As a Quality Management System (QMS) manager having a robust, efficient, and effective QMS is key for a cGMP compliant pharmaceutical operation. The processes for Change Control, deviations and Corrective and Preventive Actions (CAPAs) resulting from the same are in place, needs follow-up, monitoring, facilitation, and organization.

Key Responsibilities:

• • Issue, control, maintain, and archive forms and registers for change control and deviation either in paper, semi-electronic or fully electronic form.
  • Register, follow-up, and monitor timely close out of all Change Controls and deviations.
  • Register, follow-up, monitor and verify effective implementation of CAPAs related to deviations, market complaints, recalls, Out-of-Specifications (OOSs).
  • Organize and invite for Change Control Committee (CCC) meetings for major, complex, or contentious Change Controls and minute the meetings.
  • Report monthly and trend quarterly Change Controls, deviations, and CAPA closures on an aggregated level.
  • Participate in investigation teams to find root cause for quality related events such as, deviations and Out-of-Specifications (OOSs).
  • Perform impact assessment and/ or risk assessment procedure in evaluation of deviations and change control.
  • Prepare, review, and maintain Standard Operating Procedures (SOPs) related to Change Control, deviation handling and related CAPA handling and to train the same in time.
  • Ensure all time readiness for audit of the QMS by maintaining highest compliance to established standards and regulatory requirements.

Qualification and Experience:

Must Have: Minimum Requirements
To be considered, these minimum requirements must be evident on your resume.

• • Education: At minimum Bachelor’s degree (or higher) in Pharmacy, Chemistry or Technical Sciences.
  • Experience: Desirable 5 years’ experience in the pharmaceutical manufacturing industry within Quality Management.
  • Language skills: Fluent in English both verbal and written.
  • IT skills: Intense knowledge of an eQMS systems, ideally having managed an eQMS project
  • Knowledge of current Good Manufacturing Practices (cGMP) according to Kenyan and WHO standards.
  • Knowledge of international standards on Computerized System Validation (CSV).

Management Skills:

• • Supervisory skills and results orientated.
  • Effective time management skills.
  • Sound knowledge of GMP concepts.
  • Ability to work under minimal supervision, identify and resolve problems in a timely manner.
  • Integrity and honesty.
  • Good communication and interpersonal skills.
  • Team player with influencing and organizational skills.
  • Initiative, self-driven and ability to handle extreme work pressure.