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 Qualified Person (QP) role will make an impact.
Key responsibilities for this role include:
- Ensure that product batches and their manufacture comply with the requirements of the marketing authorisation and manufacturer's licence.
- The QP must certify that the product was manufactured in accordance with the principles and guidelines of Good Manufacturing Practice
- The primary manufacturing and testing processes have been validated.
- Relevant manufacturing information has been recorded and all necessary checks and tests have been performed.
- Any deviations or planned changes have been documented and approved in accordance with a defined procedure.
- Any changes requiring a variation to the marketing or manufacturing authorisations have been approved by the regulatory authority.
- Any additional sampling, testing or inspection necessary as a result of a deviation has been completed or initiated.
- All Production and QC documentation has been completed and approved by relevant personnel.
- Audits, self-inspections and spot checks have been carried out and documented by experienced personnel, as required.
- All necessary checks have been completed as part of the batch release process, in accordance with the established procedure.
- All relevant factors directly or indirectly associated with the product or batch under review must also be taken into consideration.
- The QP will take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting batch release of products manufactured by Rottapharm Ltd. and their subcontractors.
- To participate in the Change Control procedure in accordance with the relevant SOPs.
- To report any issues that may compromise personnel safety.
- To participate in all training and assessment activities related to the job.
- To highlight training needs and assist in the provision of training necessary to maintain GMP compliance.
The minimum qualifications for this role are:
- Must have a third level qualification in a scientific discipline
- Relevant experience in the pharmaceutical industry.
- The person must have fulfilled the education requirements for the role of the Qualified Person (Pharmacist with the relevant experience or a Diploma in Pharmaceutical Manufacturing Technology).
- Experience in Oral Solid Dosage pharmaceutical manufacturing would be beneficial.
- Strong organizational skills with the ability to multitask and prioritise workload.
- Proficiency in speaking, comprehending, reading and writing English is required.
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.