Quality Intern

Descrição

Reports To: Quality Manager

Scope & Dimension of the Role

Scope & Dimension of the Role Scope and dimension of role covers all local Quality activities and responsibilities in East Africa including:

• Commercial Business Unit

• Distribution Centre

• External Manufacturing Organizations

• Supplier Management

• In-Market Quality Activities

Responsibilities/ Accountabilities

1. Support the Quality Manager to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the Business Unit.

2. Support the implementation and maintenance of effective QMS to ensure that local operations are in full compliance with the company's Global standards and policies, GMP, GDP and regulatory requirements by supporting the Quality Manage.

3. Change Control- perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress  of changes and close out when completed.

4. Risk Management- perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.

5. Corrective and Preventative Actions (CAPA)– assist with the training and implementation of global or local process to effectively manage corrective and preventative action plans. Assist cross functions to conduct adequate root cause analysis exercises and to investigate deviations and develop CAPA’s. Ensure the local process in place are effective and within revision date and that measures are in place to track and review CAPA plans on routine basis. Demonstrate that BU effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.

6. Auditing- perform day to day work to support the local process that is in place for self-inspections. Work with the Quality Manager to ensure that the self-inspection auditing process includes clear accountability for sign off audit reports and resultant CAPA/ Risk management.

7. Complaints- perform day to day work to support an effective complaints management process ensuring the assessment of potential issues and reconciliation to effective closures are documented and filed as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate. Report and follow up on product complaints with manufacturing sites, customers and commercial teams. Perform monthly trends.

8. Incident management– Support the Quality Manager to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global recall process. Assist the Quality Manager in any investigations triggered by local incidents.

9. Product supply- performs day to day work to support systems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements. Perform import packaging checks and visual inspection checks of all imported products, returns from the market and product destined for destruction.

10. Local Repacking and Embellishment– perform day to day work to support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Prepare rework and repacking protocols. Ensure appropriate documentation of batch records and retention of samples. And perform a visual inspection of reworked stock to be signed of prior to final release.

11. Maintain the document management system and support the business unit with the issuance, control and logging of all controlled documents and records.

12. Supplier Management: Follow up on supplier issues, CAPA and performance.

Qualifications/ Experience

• At least 1 year working experience in Quality and Assurance related activities.

• B.Sc./HND in the Applied Sciences

• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits.

• Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.

• Clear understanding to ensure operations do not compromise the quality of products

• Knowledge of requirements pertaining to GMP/GDP regulatory

• Knowledge on effective quality documentation systems

• Good understanding of typical regulatory requirements relevant to a regulated product ISO9001, ISO 13485, KEBS, PPB etc.

Key Competencies/ Personal Attributes

• Results oriented, entrepreneurial and self-motivating

• Ability to deliver clear communications and foster excellent working relationships with peers and management

• Strong leadership, motivational and interpersonal skills

• Capable of building strong working relationships

• Commercial understanding of corporate and operational business issues

• Ability to transform solid thinking into action (a thinker and an achiever)

• Good communication skills both written and oral (in English)

• Strong intellectual curiosity

• Appetite for exploring new and previously uncharted territories

• Openness to change and ability to think out of the box

• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods

• Good Presentation skills

• Intermediate experience with Excel, Power point and Teams.

• Experience with working on Electronic QMS.