LOC Quality Executive at Tusen Consulting

Job Purpose

• Providing effective and efficient quality assurance systems support to the LOC Quality Lead, including supporting the implementation and maintenance of the QMS and as directed by the LOC Quality Lead.
• Ensure that the quality systems required by the LOC element of the Supply Chain and the Nigeria LOC are performed in a lean and efficient way to meet the compliance standards of the QMS and the local regulations.

Key Accountabilities / Responsibilities
Quality Strategy:

• Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
• As required, act as the relevant LOC quality contact for the Export Markets Quality organization providing communication to the Export Market Quality organization on progress on QMS compliance status updates on quality plans and escalation of issues. Share learning's and issues appropriately with other LOC and regional colleagues.
• Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans at a high level as they potentially link to day to day and quality improvement activities.

Quality Systems:

• Support the LOC Quality Lead to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC element of the Supply Chain and LOC Nigeria.
• Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with standards and policies, Guide for Commercial Companies, GMP, GDP and Regulatory requirements.
• Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to SOPs, GQPs, and GQMPs as relevant.
• Promote QMS principles and seek continuous improvement of the processes.
• Ensure CAPAs resulting from Deviations and Incidents management are well documented and effective.
• Support the management monitoring and internal auditing process in place to maintain compliance.
• Review and conduct impact assessments and implement any updates to QMS policies.

Management Monitoring:

• Conduct management monitoring on quality procedures to ensure compliance
• Support to execute independent business monitoring internal and external audits
• Monitor and track adherence to management monitoring and independent business monitoring audit schedules.

Product Supply:

• Perform 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.
• Responsible for the review and at the direction of the LOC Quality Lead, the approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.
• Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details. Ensure timely local quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries.
• Support the LOC Quality Lead with communication to the GMS supplying sites, R&D and Regional Export Quality as it relates to approval of repacking activities and resolving Quality issues with the product supplied

Artwork Management:

• Perform tasks in line with the roles and responsibilities for quality as defined in the local artwork procedures.

Batch Release & Local Repacking:

• Perform responsibilities to support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export.
• Ensure as appropriate documentation of batch records and retention of samples.

Other:

• Acts in the role of the Quality Systems Lead in the absence of the LOC Quality Lead.
• Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with companys policies.
• Ensures all product specifications and related documents (e.g. C of As, TTs) are maintained compliant to current registered details.
• Maintains and updates the LOC Quality local standard operating procedures as required.

Knowledge / Experience / Skills / Competencies Required
Education and Experience:

• Successful completion of relevant tertiary qualifications - Science Degree.
• Minimum of 2 years’ experience within the Pharmaceutical and Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
• Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits.
• knowledge of regulatory requirements pertaining to GMP/GDP.
• Knowledge on effective quality documentation systems.

Essential Skills and Abilities:

• Professional written and verbal communication skills.
• Ability to deliver clear communications and foster excellent working relationships with peers and management.
• Analytical mind, good attention to detail and problem-solving skills within a structured process
• Good team player - works well in cross-functional teams
• Ability to multi-task and work under pressure
• Concise in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Work with a spirit of continuous improvement and innovation, creativity, open to new ideas and methods.