Quality Manager - External Manufacturing AMET

Job title: Quality Manager - External Manufacturing AMET

• Location: Cairo, Egypt

At Opella Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

About the job

Manage third party manufacturers located in this region. Products are for local market and export markets. Perform regular monitoring and assessment of contracted GMP activities.

• Serve as functional quality representative of external manufacturing AMET for CMOs in work scope.
• Ensure that the transfer of a manufacturing process and analytical methods throughout product development and lifecycle, from a Sending Unit (SU) to a Receiving Unit (RU), is conducted in a planned, controlled, organised, efficient, and well documented manner with well-defined success criteria for all transfer phases.
• Ensure that manufacturing operations are performed, and products are manufactured in accordance with GMP, the marketing authorisation and the quality agreement.
• Contribute to business operation by establishing partnership with third quality manufacturers and providing quality oversight and support for quality operations activities.
• Any ad hoc tasks assigned by the reporting Manager.
• Candidate may be required to adjust work schedule as needed based on the time zone of stakeholder, have effective communication skills to liaise with stakeholders across different time zones and be able to work collaboratively with a remote team.

Major Duties & Responsibilities

1- Quality Management of third-party manufacturers

• Perform GMP audits of third-party manufacturers and CAPA (Corrective action and preventive action) follow-up.
• Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
• Management and support product recall and return.
• Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
• Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
• Participate in the evaluation, selection, and approval of third-party manufacturers.
• Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
• Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
• Review of technical reports e.g., stability reports, process /analytical validation reports etc.  
• Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
• Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
• Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third-party manufacturers.
• Perform risk ranking of third-party manufacturers.
• Manage termination of activity with third party manufacturers.

2- Quality Operations of EM CHC AMET Entity

• Support Technology Transfer to ensure adequate process, testing, and product knowledge transfer from SU that possesses the knowledge, history, and operational experience to RU that needs to acquire the knowledge and leverage available experience to establish and sustain the transferred process and technology.
• Transfers of end-to-end manufacturing processes along with their supporting analytical methods, from starting materials preparation, seed and cell bank preparation, active pharmaceutical ingredient (API) manufacturing, and formulated drug substance manufacturing to finished product (FP) manufacturing.
• Support/perform management and continuous improvement of Quality Management System (QMS).
• Support/perform implementation of global quality standards and procedures.
• Support Quality Documentation System management, documentation Retention, Archival and Destruction.
• Support/perform Qualifications and Training of Quality/Regulatory personnel.
• Support/perform Self Inspection.
• Prepare and participate in EM CHC AMET Quality Review.
• Support/prepare Monthly Quality Reports for reporting to Global Quality.
• Collect and consolidate the quality KPI’s (Key Performance Indicators) of third-party manufacturers for reporting to Global Quality.

3- Quality Support for Transversal Projects

• Provide Quality support for transversal project e.g., new product launch, site transfer or repatriation.

About you

• Experience: 8 years working experience in quality or manufacturing in pharmaceutical industry.
• Soft and technical skills:
• Ability to work in a matrix organization.
• Good team spirit and familiar with project development through cross-functional activities.
• Strong organizational and negotiation skills.
• Knowledge and understanding of Quality Control Analytical methods.
• Knowledge and understanding of Installation Qualification, Operational Qualification and Process Qualification processes and techniques.
• Pro-active with good sense of responsibility.
• Balanced Judgment / Risk based approach.
• Analytical thinking, hands-on troubleshooting style.
• Able to work independently and write technical reports.
• In depth knowledge of pharmaceutical/nutraceutical/cosmetics/medical devices GMP and regulations (ASEAN, EU, ICH, PIC/S, local market GMP regulations).
• Computer skills: Word, Excel, Phenix / CONNECT (Quality tool and GMP Documentation system).
• Languages: Strong interpersonal and communication skills (writing & verbal) with excellent command of English.