Meda Pharma, S. de R.L. de C.V.
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 Coordinator / Sanitary Responsible role will make an impact:
Establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within Mexico ́s Affiliate to ensure compliance with Viatris and Regulatory Authority expectations
Quality Responsible Person (Responsible Pharmacist) related to distribution activities, focusing on the management of authorized activities and the accuracy and quality of records.
Point of contact for investigations and resolution of product quality issues detected or originating in the Affiliate and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Supply, Medical, Third-Party warehouse, Business Units ) and Viatris Manufacturing sites on such issues.
Monitors the product quality and compliance activities within the Affiliate, to ensure current regulatory expectations are met, and facilitate internal and regulatory GDP/GMP inspections.
Responsible Person backup of additional Legal Entities of the affiliate
Key responsibilities for this role include:
Quality Management System
- Maintains up to date 'control logbooks' to document imports, national purchases, sales,



product returned and destruction' to maintain product balance.
- Elaborate yearly 'quota requests' to Health Authority for importing finished goods, API and analytical standards on a yearly basis.
- Be the liaison with the Health Authority to manage any requirement for the warehouse operation (like product disposition).
- Supports maintenance of a Quality Management System and a Quality Culture within Affiliate in compliance with internal and Regulatory Authority expectations.
- Ensures timely implementation of all applicable Quality Policies, SOP's and WI within the area of responsibility.
- Ensures Implementation of corresponding training for personnel in the Affiliate due to update and/or creation of Quality Policies, SOP's and WI as applicable.
- Ensures that initial and continuous training programs are implemented.
- Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.
- Ensures that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place, tracking the implementation of the identified actions within agreed timeframes.
- Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.
- Ensures that any additional requirements imposed on certain products by national law are adhered to.




- Keeps appropriate records of any delegated duties.
Local Product Disposition
- Responsible for the local release of products under the distribution license of the Affiliate Legal Entity, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
- Supports Quality oversight of any required Quality release activities, such as but not limited to:
- Batch record review.
- Artwork Compliance check and Safety Variation implementation.
- Ensures and documents control of product certificates and transportation / temperature records obtained from product's transportation for replenishment.
- Decides on the final disposition of returned, rejected (destruction), recalled or falsified products (defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center) and documents process as per Viatris and Regulatory Authority requirements.
- Coordinates and promptly performs any recall operations for medicinal products.
- Initiates the required actions if counterfeit products are identified.
Change Controls
- Support Management of planned, permanent, and temporary changes of GMP's /GDP related activities and systems in the Affiliate.
- Ensures change actions completion as per the agreed timelines.
Subcontracted Activities with GMP / GQP / GDP Impact
- Approves any subcontracted activities which may impact on GMP / GDP: Develops, Negotiates and maintains up-to-date Substances Requirements, Transportation and Logistics Service Providers (LSPs).
- Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors
- Establishes and maintains a pe

📌 Coordinator/Sanitary Responsible (Xico)
🏢 Viatris
📍 Xico