ViatrisCoordinator/Sanitary Responsible
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 personal contact with relevant contractor representatives including the Responsible or Qualified Person to regularly review and assess quality systems, quality performance and agree action plans to ensure continuous improvement.
- Oversees quality operations at contractors which includes but is not limited to:
Contractor Assessment and Approval ensures all GMP/GDP contractors have been formally assessed and approved.
Deviation Management: evaluates the impact of all significant deviations affecting safety, identity, strength, purity and quality, generated at the contractor and agrees corrective actions. If necessary, initiates the “Critical Quality Notification to Management” process.
Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement
Issue and review Metrics: periodically assess the overall quality risk associated to the contractor. Acts on adverse trends to improve contractor quality and compliance performance.
- Facilitates the Corporations Internal Audit-Functions audit process at the contractor. Helps to define action plans for improvement and follow-up and communicate action closures.
Product Quality and Compliance Issues
- Deviation Management in conjunction with the Global Quality Operations as applicable.
- Initiates the “Critical Quality Notification to Management” process if required
Customer Complaints handling
- Ensures that customer complaints on product quality are dealt effectively.
- Management of product quality complaints from customers, assignment of class and criticality to each case and forwarding to the appropriate investigating Site.
- Tracks investigation results in a timely manner.
- Informs Quality Management of significant complaints.
- Initiates the “Critical Quality Notification to Management” process if required
The minimum qualifications for this role are:
Education: Pharmaceutical degree or a degree related to healthcare and sciences, as required by regulations for the position of Sanitary Responsible registered with Cofepris.
Knowledge: Strong understanding of quality principles, concepts, and theories, including quality management systems and regulatory requirements such as GMP/GDP, Control Drug Substances regulations (NOM-05, FEUM, Suplemento de establecimientos dedicados a la venta y suministro de medicamentos e insumos para la salud, NOM-072, NOM-073).
Experience:
Minimum 3 years in the pharmaceutical industry, specifically working with controlled substances.
At least 1 year as Responsible Person for controlled substances.
Skills:
Fluent in English (verbal and written).
Preferred experience with electronic systems (SAP, Trackwise, Minitab, etc.).
Previous experience with compliance or regulatory authorities is a plus.
Excellent communication skills with internal and external stakeholders.
Self-motivated, proactive, and able to work effectively in cross-functional teams.
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.