Dirección
forma de trabajo Location:#LI#CDMX#Hybrid
About the role:
This opportunity offers an impactful role in supporting laboratories in America, particularly in Brazil, Argentina, and Mexico. The position involves crucial responsibilities such as budget follow-up and optimization, ensuring materials availability, and enabling timely product release to the market. By contributing to these efforts, candidates will directly contribute to providing patients with timely access to their treatments, making a meaningful difference in their lives.
Main Responsibilities:
•Verify the issuance and updated guidelines, regulations, and policies related to drug products analysis, in accordance with local, regional, and global standards. Guarantee region compliance according to current health authorities’ regulations and applicable guidelines as well as corporate standards.
•Prepare, update, and review standardized operating procedures and work instructions, guaranteeing reproducible processes that fulfil regional and global regulations health authorities and corporate normative. Assist and support internal and external audits. Establish and verify timely execution of all CAPAs derived from these audits. Collaborate in appropriate resolution of all deficiencies detected during health, internal, corporate and security authorities’ audits.
•Propose, lead, and actively participate in initiatives and projects to improve quality practices and efficiencies at a local, regional and/or global level. Create, manage, and implement strategies for the purchase and administration of Laboratory Supplies at local level, coordinating the vital documentation among applicable partners.
•Create and implement regional strategies for Laboratory Supplies harmonization, in accordance with Global Laboratory Supplies strategies. Analyze, evaluate, detect and propose solutions for mitigation of inventory management risks, related to QC laboratories everyday operation.
•Collaborate with QC and SCM to prepare and implement analytical programs of Release and Stability. Coordinate, build and/or handle Purchase Orders and import processes of Laboratory Supplies for QC laboratory.
•Set, coordinate, and make de follow up of regional alignments throughout supplies purchasing process in order to fulfil customer needs. Responsible for data compilation and preparation of dashboard/data bases on regular basis to track and report deliverables. Regularly communicate with partners to collect feedback on supported processes.
•Report and record Issues, Deviations, Quality Events emerging from process delivered, and communicate progress as appropriate in collaboration with team leader. Ensure efficient, timely and clear communication to all involved partners (local and global functions) as required for follow-up on activities under scope.
•Build and maintain high expertise and continuously acquire process knowledge. Support and participate in the implementation and modification of services.
