Senior Specialist, Quality Assurance

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 this role will make an impact:

Key responsibilities for this role include:

• Manage core activities of the QOO team.

• Quality Management Systems:

• Management of Complaints, Escalations, FAR. Approval of Investigations, OOS, CAPAs.   

• Manage and support the Internal Audit Program.

• Vendor Management:

• Support Approval of Vendor/TPM, Carry out risk assessment including assisting in scheduling of Vendor and TPM Audits.

• Support the preparation and control of Technical Agreements and Confidentiality Agreements.

• Product Technical Transfer:

• Act as Quality Subject Matter Expert for Key Product Development and Product Launches.

• Support, Review and Collate data for Technical Transfer and Process Validation including but not limited to data on raw materials, finished product, equipment, process, method validation protocols and reports, and stability protocols.

• Batch Review Coordination:

• Review and Management of Batch review of TPM (Third Party Manufacturers) Manufactures.

• Approval of TPM sites Investigations including laboratory OOS, non-conformances and timely closure of CAPAs,

• Review of Product Quality Reviews where applicable

• Where applicable, Act as Deputy Responsible Person (RP), duties listed in procedure ‘Responsible Person Duties and Responsibilities’ and include management of authorized activities and the control of Wholesale Distribution, ensuring compliance with EU Good Distribution Practice of medicinal products within EU (GDP directive 2013/C343/01).

• Deputize for the QA Manager (QOO Affiliates) as required

The minimum qualifications for this role are:

• Bachelor’s degree (or equivalent) in a Science related discipline with 6+ years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department is essential. Experience of sterile injectable manufacturing and third party site quality management desirable but not essential. However, a combination of experience and/or education will be taken into consideration

• Must possess knowledge and experience of all quality system aspects including: Deviation management, CAPA, Complaint handling, auditing, change management, supplier qualification, vendor management and batch release.

• Knowledge of Quality …