Quality Assurance Sr. Associate (Egypt) Contractor

The Company

iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.

The Opportunity

We currently have an opportunity for a Quality Assurance Sr. Associate (Egypt) Contractor to join our Quality Assurance team

Position Purpose :

The Senior QA Associate (MENA) is responsible for the following:

• To maintain a consistently high-quality standard across our product portfolio (responsibility primarily for consumer healthcare products)
• To manage and monitor the quality oversight of our product portfolio; ensuring the necessary quality activities, assessments, and monitoring are being effectively conducted by our network of manufacturing and distribution partners
• To work with manufacturing and distribution partners in support of the implementation of established continuous improvement programmes
• To collaborate across functions, creating a more collaborative quality function, and drive a quality mindset throughout the organisation
• To maintain policies, procedures, and quality systems in compliance with a) government guidelines, b) regulations or work practices; and c) corporate expectations
• To be responsible for the following areas:
  • Quality oversight of Contract/External Manufacturers (CMO/EMO)/3rd party logistics providers/Distributors to ensure the relevant quality processes have been conducted and are not duplicated by iNova
  • To write, review &/or authorise Quality documents and procedures as defined e.g., SOPs, WIs, forms, PQR, Deviation and Quality investigation reports
  • To maintain and manage Quality Management System (QMS) e.g., Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoring
  • To support due diligence checks for new external contract manufacturers, new products and support external audits as required
  • To support the maintenance and improvement of the quality system.
• To be responsible as Technical Responsible Person or Responsible Pharmacist in Cosmetics Distributor.

To have access to the 3rd party logistic/distributors warehouses to ensure quality oversight of the storage and distribution activities when required.

Key Accountabilities & Performance Indicators :

The following outlines the accountabilities and deliverables of the Senior Associate of Quality Ops (MENA)

• Work in collaboration with contract/ external manufacturer, and internal functions to ensure EMO partners conduct the required quality oversight, through OOS/NCR/ Deviation and CAPA, Change Control and routine stability testing monitoring, on time and in compliance to GMP and applicable standards
• Work in collaboration with 3rd party logistics providers/distributors and internal functions to ensure they fulfilled the requirements of GDP and applicable standards on a timely basis.
• Manage the product release process to a < 3-day timeframe from batch receipt, while minimizing recall incidences or critical product quality issues
• Manage and oversee change control processes, and action on individual change controls within the defined target dates and in compliance to GMP/GDP and iNova SOPs
• • Manage and oversee individual deviations, NCR & CAPA processes, and action on them in compliance with GMP/GDP and iNova SOPs, and in alignment with timeframes of iNova’s business needs, to minimise recall incidences or critical product quality issues
  • Collaborate with functions to ensure complaints are managed and resolved according to compliance requirements of regulations and SOPs within the required timeframes
  • Support internal and external audits activities to ensure audit findings are resolved within the agreed timeframes
  • Collaboration and stakeholder management
  • Supports region in driving a quality mindset across operations
  • Collaborates closely with the wider iNova organisation to ensure quality activities are completed and in compliance to regulation requirements and SOPs
  • Takes initiative to support other functions in quality operations activities where relevant
  Functions as an integral part of the Quality Ops team

Qualifications, Skills, and Experience :

• Minimum requirement is a tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related Science or Engineering discipline.
• 5 years in the pharmaceutical industry with at least 3 years of QA experience in the pharmaceutical industry. Experience in supply chain quality, manufacturing quality or quality organization in a commercial business
• Working knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), deviation management, CAPA, change control and documentation management in a pharmaceutical industry
• Good understanding of the Quality Management System (QMS)
• Holds the required pharmacist/pharmaceutical technical person license as per mandated by local regulations (Drug/Cosmetic)

Personal Attributes :

• High ambiguity tolerance and openness to change.
• Embrace a collaborative way of working when working with various other teams
• Practice a growth mindset; to continually learn and improve
• Able to handle multiple tasks in a fast-paced environment
• Be able to work independently by taking ownership of their work and identifying appropriate next steps required to deliver on their work
• Understands and embraces change and the transformation agenda
• Strong customer focus (with respect to internal and external ‘customers’)