Supply Chain Quality Senior Specialist
Job Description
VIATRIS MIDDLE EAST FZ-LLC
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 Supply Chain Quality Senior Specialist role will make an impact:
Key Responsibilities Include
The Supply Chain Quality Senior Specialist will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Global Quality, Internal sites and R&D) and will lead and participate in virtually based cross functional teams.(S)he will report to the Supply Chain Quality Manager-Middle East Region.
- Act as deputy Responsible Pharmacist for Viatris Middle East GSDP.
- Support, as quality representative, new product launches, new Business Development projects and technology transfers.
- Partner with colleagues to develop and negotiate quality agreements.
- Drive the development, implementation and continuous improvement of Quality Systems to support regulatory requirements.
- Proactively support regulatory inspections at CMO's and ensure appropriate Viatris review/approval of responses to Regulatory Agencies including tracking of CAPA's within Quality Tracking System (TrackWise).
- Provide Quality Leadership for change management and significant deviations at distribution sites that may impact compliance status or require regulatory notifications.
- Provide Quality Leadership and author support documentation for individual market release supporting documents to meet local regulatory requirements.
- Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
- Prepare Critical Quality Event (CQN) summaries and participate in relevant meetings.
- Lead quality risk management activities and manage mitigation plans within CMO's.
- Accountable for the on-time disposition of commercial products in line with agreed schedule.
- Provide Quality leadership for customer complaint investigations.
- Provide support for regulatory activities involving TPQ managed Contract manufacturers.
- Lead and/or provide support to quality projects and continuous improvement initiatives within TPQ and External Supply.
- Primary focus of the role will be to support local Gulf, Levant & ITB Quality Operation identified which require liaison, information sharing, review and approval of documents and generation of deal specific documents, eg APQR's, complaint trend evaluations et.
- Provide Quality support within the cross functional teams.
- Participate in the establishment and maintenance of a Quality Management System and Quality Culture within Viatris Country in compliance with internal and Regulatory Authority expectations.
- Participate in GDP/GMP internal audits and regulatory inspections within Viatris Country Office
- Track quality metrics, assess risks and implement actions to continuously improve performance.
The Minimum Qualifications For This Role Are
Education and Training- Hold Bachelor of Pharmacy/Pharmaceutical sciences degree is a Must.
- Holding Quality related certificates is preferred.
- Hold Pharmacist License from MOHAP - UAE.
- Advanced computer skills, MS Office and enterprise systems such as SAP, TrackWise, Documentum platforms .
- Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader.
- Self-Motivated; Operates with minimal supervision.
- Demonstrated experience managing complex quality and compliance activities in a distribution center, Affiliate or with a contractor.
- Demonstrated personal leadership to manage cross functional projects.
- Demonstrated ability to resolve conflicts.
- Takes initiatives and is proactive, persistent.
- Command of English language required, must be also fluent in Arabic; multi-lingual is beneficial.
- Strong verbal and written communication including presentation skills.
- Shows strong negotiation skills.
- Is diplomatic in communication with internal stake holders and external customers.
- Minimum 3 years in a GxP setting.
- GMP experience is a plus.
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.
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.