Pharmacist Executive, WorldWide Healthcare

Job Function

• The Quality Assurance Executive will support the Quality Assurance Manager in coordinating, implementing and maintaining quality assurance activities across WWCVL Nigeria.
• The role will provide experienced oversight of product quality complaint management, GDP and QMS training, quality documentation and reporting, investigations, CAPAs, change controls, recalls, audits and other assigned Quality Management System activities.

Key Performance Areas
Product Quality Complaint Management:

• Receive, acknowledge, log, assess, track and maintain complete records of product quality complaints.
• Coordinate and support complaint investigations by obtaining relevant product, batch, distribution, transportation and storage information from responsible departments.
• Review complaint information to ensure that investigations are thorough, properly documented and supported by appropriate evidence.
• Maintain complaint trackers and follow up to ensure that investigations, corrective actions, customer responses and closure records are completed within agreed timelines.
• Communicate with principals, customers and relevant internal departments regarding assigned complaint matters through approved channels.
• Analyse and trend complaint data to identify recurring issues, overdue investigations and opportunities for improvement.
• Prepare periodic complaint reports and present significant findings for management review.
• Promptly escalate serious, critical, recurring or overdue product quality complaints to the Quality Assurance Manager.

Quality and GDP Training Management:

• Maintain the Good Distribution Practice and Quality Management System training matrix.
• Coordinate induction, refresher and assigned GDP or QMS training activities in accordance with the approved training plan.
• Develop, review and maintain training materials, attendance records, assessment results and training-effectiveness records.
• Monitor employee training completion and follow up on overdue mandatory training.
• Provide guidance to employees and departments regarding applicable quality and training requirements.
• Support the evaluation of training effectiveness and recommend improvements where necessary.

Quality Documentation and Reporting:

• Prepare, compile, review and maintain assigned quality records, trackers and reports.
• Review records for completeness, accuracy, legibility, consistency, traceability and timely completion.
• Maintain complaint, training and other assigned quality trackers, including all relevant supporting documentation.
• Compile quality data and prepare periodic reports, summaries and trend analyses for review by the Quality Assurance Manager.
• Support document and record retrieval during regulatory, principal, customer and third-party audits or inspections.
• Monitor assigned activities and follow up on outstanding documentation and actions.
• Promptly report documentation gaps, recurring errors, data-integrity concerns and overdue actions.
• Support the implementation and monitoring of good documentation and record-management practices across relevant departments.
• Recommend appropriate corrective actions for recurring documentation or data-integrity issues.

Quality Management System Support:

• Coordinate and support investigations, root-cause analysis and the development, implementation and monitoring of corrective and preventive actions.
• Support the management of deviations, change controls, quality risk assessments, product recalls, mock recalls and other assigned QMS activities.
• Review investigation and CAPA records to ensure that identified root causes, corrections and corrective actions are appropriate and adequately documented.
• Monitor QMS actions and follow up with responsible persons to ensure timely completion and closure.
• Support product and batch release, sampling, coding, relabelling, returns and product-incident activities when appropriately trained and authorised.
• Participate in self-inspections, internal audits and preparations for external audits and regulatory inspections.
• Maintain trackers for assigned QMS activities and provide regular status updates to the Quality Assurance Manager.
• Support the implementation and monitoring of quality improvement initiatives.
• Provide quality assurance coverage during audits, investigations, emergencies, workload peaks or the absence of other team members, within the limits of assigned training and authorisation.

Audits and Inspection Readiness:

• Participate in the planning and conduct of internal audits and self-inspections.
• Support preparations for regulatory, principal, customer and third-party audits and inspections.
• Coordinate the collation, review and presentation of requested quality records and supporting evidence.
• Monitor audit and inspection observations and ensure that assigned responses and corrective actions are completed within agreed timelines.
• Support the development of responses to audit and inspection findings.
• Follow up with responsible departments to verify the effective implementation and closure of corrective actions.
• Promote continuous inspection readiness across relevant departments.

Stakeholder and Compliance Support:

• Maintain professional working relationships with internal departments, principals, customers, suppliers, service providers and relevant regulatory authorities.
• Respond to assigned quality information requests accurately and within agreed timelines.
• Provide quality assurance guidance and support to junior employees and operational departments.
• Communicate identified quality risks, compliance gaps and overdue actions to the appropriate stakeholders.
• Maintain the confidentiality, security and integrity of quality, complaint and business information.

Qualifications Required

• Bachelor’s Degree in Pharmacy
• Relevant professional registration license.
• Additional training or certification in Good Distribution Practice, Good Manufacturing Practice, quality assurance, Quality Management Systems, product quality complaint management, root-cause analysis, CAPA management, quality risk management or auditing will be an advantage.

Experience and Skills Required:

• Five to eight years of progressive quality assurance experience within a pharmaceutical company, healthcare distribution organisation, pharmaceutical warehouse or similar regulated environment.
• Demonstrated practical experience in product quality complaint management and investigation; deviations, root-cause analysis and CAPA management; change control and quality risk management; product recalls and mock recalls; GDP and QMS training coordination; quality documentation, data integrity, trending and reporting; internal audits and regulatory inspections; and pharmaceutical warehousing, storage and distribution operations.
• Proven experience coordinating quality activities, monitoring compliance actions and ensuring timely closure of assigned deliverables.
• Experience providing quality assurance guidance and support to junior employees and operational departments.
• Demonstrated ability to engage effectively with regulatory authorities, principals, customers, suppliers, service providers and internal stakeholders.
• Strong working knowledge of Nigerian pharmaceutical regulatory requirements, Good Distribution Practice and applicable quality management standards.

Application Closing Date
Not Specified.

How to Apply
Interested and qualified candidates should:
Click here to apply online

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