Quality Control Section Head

3 months ago

القاهرة, Egypt Viatris Full time

Viatris Egypt S.A.E

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the (QC Section Head/Raw Materials) role will make an impact:

- Position summary:
Responsible for the QC laboratory functions (Raw Materials) and the corresponding documentation to support the timely disposition of product.

Job Specific technical/Functional/Professional Competencies:

- Responsible for the QC laboratory functions (Raw materials & imported finished goods) and the corresponding documentation to support the timely disposition of product.
- Responsible for ensuring that all results generated are in compliance with data integrity requirements.
- Responsible for raising Notification of critical quality events whenever condition in Viatris Policies applies.
- Establish, recommend, maintain, and assure that consistent laboratory procedures and practices are followed in accordance with company policy and regulatory requirements.
- Responsible for fulfilling all regulatory requirements.
- Ensuring implementation of EHS measures/actions within QC laboratories.
- Coordinating schedule with other departments (Planning, warehouse).
- Training the analysts on the implementation of current new SOPs, Standard Test Procedures (STPs) and new techniques in the analysis. Document and approve the training documents.
- Reviewing the Analytical Method Transfer Exercise (AMTE) results from local (new analysts, new test procedures) and from labs in other companies and/or countries and supporting them.
- Review and approval of the entire SOP’s relating to raw material and ensure understanding and implementation of these SOP’s and for closing the gaps between Viatris Policies and QC (Raw material) and compliance practices.
- Troubleshooting of section problems and supporting outsourced laboratory.
- Review and approval of raw material out-of-specification and failure investigations and ensure that all steps are completed within their time frame.
- Responsible for Reviewing and approval of Raw material release documents.
- Responsible for follow-up of Raw material laboratory equipment calibration & maintenance.
- Maintains laboratory supplies inventory required for analysis.
- Responsible for handling the global changes affecting raw material laboratory.
- Supports QA with all CCRs and QARs related raw material.
- Develop new specification for raw materials when needed.
- Works in a cross functional team with procurement department / Quality assurance for supplier qualifications.
- Responsible for Audit requesting / auditing suppliers, Quality agreements execution and follow up activities with the suppliers and other user sites.
- SMS site coordinator (Viatris Supplier Management System).
- Responsible for implementation of Data integrity program in the relevant work area and ensure following up ALCOA+ principles all over operations.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Viatris Quality Standards.
- Delegate for Quality Control Manager for the release of raw materials for manufacturing.
- Delegate for Quality Control Manager in case of his absence (if needed).
- Delegate Senior Quality Control Analyst (Raw Materials) in case of absence.

Experience and Knowledge
- Good command of English in both written and spoken.
- Excellent in Microsoft office (word, excel & PowerPoint)
- Knowledgeable with interpersonal, good communication and presentation skills.
- cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
- Strong knowledge with Laboratory instruments mainly chromatographic data systems.

Essential Personal Qualifications
- Bachelor’s degree in pharmacy or science. Green belt holder is a plus.
- 5 - 7 years’ experience in a related area.
- Good understanding of the pharmaceutical regulatory process and EDA guidelines.
- Ability to interact with various priorities with good communication towards the stakeholders with good negotiation skills.
- Demonstrated ability to work independently.
- Team building skills.
- Excellent documentation and technical writing skills.
- Ability to meet deadlines.
- High observation, analytical, problem solving and good planning skills.
- Scientific and logical way of thinking.
- Time management, people management and decision-making skills.
- Active and organized with high attention to detail.
- Self-motivated with high physical and technical sk

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