Capacity building, Certification, and Compliance Manager at
3 months ago
The PharmAccess Group is dedicated to make inclusive health markets work in Africa by developing innovative products and stimulating investments through partnerships with the private sector and government institutions.
This group of not-for-profit organizations has a shared goal, working towards improving access to better healthcare in Africa.Responsibilities
The Quality Manager is responsible for:
Works in collaboration with the SafeCare Director in the development of SafeCare's strategic goals and objectives.
Implements, evaluates, revises, and achieves performance outcomes of SafeCare's Strategic Plan, specifically as it relates to the Certification, Capacity Building, and Compliance.
Contributes to the creation of a workplace culture of purpose, and results, ensuring collaborative, strategic, and values-based decision-making that results in high team morale, cross-departmental engagement, and effective customer service.
Monitors and maintains accurate Certification, Capacity building & Compliance performance metrics and prepare reports on the same to the SafeCare Director on a monthly basis.
Quality:
Serves as the lead SafeCare Quality manager.
Oversees the implementation of process management activities in Kenya in consultation with SafeCare Amsterdam.
Supports the onboarding process for license partners, and public entities.
Ensures that assessments conducted by SafeCare License Partners comply with all relevant requirements and that the assessments have been conducted in accordance with all SafeCare and
ISO :
2015 procedural requirements, including team competence, audit time spent, structure of audit plan, etc.
and to confirm that the output of the assessment is technically appropriate and adequate to support the recommendation of the assessment team.
Raises queries to the relevant assessor (s) if any non-compliance is noted.Performs assessment reviews in a timely manner in line with the SafeCare customer charter.
Participates in the Certification review committee as outlined in the certification committee TOR.
Manage complaints from health providers and licensee partners.
Capacity Building:
Ensure effective technical assistance for MCF clients and MomCare clients.
Ensures License partner capacity building plans are defined based on partner assessment with input from the Business Development Team in Amsterdam.
Develops and implements plans for training and validation reviews for PharmAccess Kenya assessors and license partner assessors.Ensures License Partners are trained and follow SafeCare policies and procedures.
Coach license partners to improve their business systems and processes so they can grow their businesses and be sustainable.
Compliance:
Maintain PharmAccess Accreditation status with KENAS.
Supports the development and implementation of all policies, ensuring those policies are documented and accessible to staff.
Oversees implementation of standards including changes to regulations, standard operating procedures, work instructions, or guidance documents.
Participates in the review of the application and supplementary information for the certification/accreditation process jointly with the SafeCare application review committee.
Participates in the SafeCare Management review committee in Kenya.Participates in KENAS audits and accreditation related activities as needed (site visits, witness, audits, etc.)
Oversees the preparation and submission of accreditation documents required by KENAS to maintain accreditation.
Performs tasks required to close non-conformities identified during audits.
Leads the Quality Assurance approach for license partners in Kenya and develops a strategy in consultation with the other countries and SafeCare Amsterdam.
Other:
Supports program reporting activities (drafting sections, gathering inputs, editing success stories).
Maintains an open and professional relation with team members, promoting a strong team spirit.
Maintains professional and job-specific knowledge by attending workshops, establishing personal networks, and
participating in professional associations.
Adheres to and act in accordance with the PharmAccess HR Policies and Procedures.
Any other task relevant to these duties or the mission of the organization as may be assigned from time to time.
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