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.
- 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).
- 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.
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