Ipc Section Head

6 months ago

مصر, 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 (Quality Assurance - IPC Section head) role will make an impact:
Position summary:

- Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site through managing IPC Functions.
- Prevent any potential cGxP compliance gaps and risks and ensure remediation activities for all existing gaps, to ensure ongoing compliance.

Job Specific technical/Functional/Professional Competencies:

- Leading & Supervising the In-Process Control laboratory through:

- Coaching the IPC team towards achieving high performance.
- Troubleshooting the daily production deviations.
- Ensure & oversight the GMP standards in the production.
- On-Job training for IPC team.
- Managing lab resources & equipment status.
- Ensure that IPC procedures & test methods are comply with the updated Viatris specifications & regulatory requirements.
- Review & approve the site’s standard operating procedures, Quality assurance profiles, master bill of material & Master batch records.
- Admin of all IPC instruments and managing all compliance activities related.
- Share in the preparation for and escorting of quality-related audits conducted by Corporate and regulatory agencies.
- Lead & Member of the Internal Audit Team.
- Backup in the review of “C of A (Test Notes)” before submission to MOH.
- Responsible for IPC Compendial test method updates review & required activities.
- Acts as QA Manger deputy in approval of the site investigation reports.
- Interface with regulatory agencies to discuss lot records, manufacturing procedures, test results, and labeling as required.
- Responsible for Training of IPC team.
- Responsible for supervision of Vendor related IPC activities (Equipment qualification /maintenance /repairs & others).
- IPC vendors communication & handling.
- Responsible for purchasing of IPC consumables.
- Responsible for authoring quality related documentation (SOPs, Controlled documents, Risk assessments,etc.)
- Responsible for coordinating the weekly overtime shift for IPC staff.
- Managing Retain sample store and also review & approve Retain store documents.
- Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA principles all over operations.
- Responsibility for compliance with Viatris Quality Standards.
- Delegate Quality Assurance manager in case of his absence (if needed).
- Delegate Senior Quality Assurance IPC Associate in case of absence.

Experience and Knowledge:

- Bachelor’s degree in pharmaceutical sciences.
- At least 7-10 years’ experience in Quality in Pharmaceutical industry field.
- Experience in manufacturing processes.
- Experience with relevant TW modules.
- QRM practitioner.

Essential Personal Qualifications
- Strong interpersonal and influential skills.
- Excellent in communication and project management.
- Decision-making based on a risk science-based approach.
- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- High communication, teaching, and coaching skills.
- Good Logic way of thinking with high analytical skills.
- Good planning and organization skills
- Management and decision-making skills.
- High analytical skills.
- Professional in reports writing.

Preferred Qualifications:

- Six Sigma (Green Belt) is a plus.
- Experience with relevant TrackWise modules.
- QA/QC and Manufacturing Operations experience.
- Team leader/project leader.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

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