Job Openings at Dawa Limited

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 in the role would involve, but not limited to:

• 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.

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The Position: As a compliance manager you will focus on adherence to Quality Management Systems, maintaining compliance at the highest standards, and ensuring that the company’s policies, procedures and processes are in line with regulatory standards and requirements. You will be based in Nairobi and directly reports to the QA Manager.

Key Responsibilities:

• Responsible to identify non-conformances and provide technical information on shopfloor and in system through routine walkthroughs.
• Ensure timely completion of batch manufacturing records and its review to facilitate quality decision on the product.
• Lead failure investigations related to shop floor non-conformances to identify root cause and appropriate mitigation action plan.
• Monitor timely closeout of CAPA related to failure investigations and ensure its effectiveness.
• Monitor and maintain compliance with respect to GMP, GDP and legal requirements.
• Lead the in-process quality assurance team with functional and disciplinary accountability.
• Coordinate with IPQA supervisors and IPQA officers for implementation of GMP/GLP/GDP.
• To perform, monitor and approve in-process controls.
• To monitor and control manufacturing environment.
• To monitor and control plant hygiene.

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

• Education -Minimum Bachelor’s degree in Pharmacy or equivalent from a recognized institution.
• Experience – minimum 2 years’ experience of which should be in a similar position.
• Professional qualification-preferably registered by the pharmacy and Poisons Board, Member of Pharmaceutical Society of Kenya.
• Knowledge of current Good Manufacturing Practices (cGMP) according to Kenyan and WHO standards.
• Should be proficient in use of computer office applications i.e MS Office and SAP system.

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.