We are the established global leader in generic antibiotics, with 50-plus medicines serving more than 200 million patients per year. We have a leading global program to combat antimicrobial resistance (AMR), taking a balanced, cross‐sector approach to combatting this unprecedented global health threat. Our goal is simple: to ensure patients continue to receive the medicine they need, when and where they need it.
Your Responsibilities Will Include
Manage the QC & AST Chemical and Nitrosamines labs of Palafolls site.
Guarantee that the work in the QC & AST lab is carried out in accordance with the requirements of the Sandoz Quality Manual and complying with GMP and GLP regulations.
Coordinate the work teams in the QC & AST lab based on the planning and needs of the site.
Guarantee in a controlled way the level of service of the site, ensuring the agreed KPIs and attend to the emergencies of the site.
Ensure the safety of the laboratory staff and propose improvements to avoid accidents.
Manage and control the budget of the whole department.
Guarantee the correct compliance with GLP's, GMP's and documentation in the analytical tests performed.
Guarantee the correct calibration/verification, qualification and maintenance of all laboratory equipment and correct management of the documentation related to instruments in accordance with the Sandoz guidelines.
Guarantee the correct management of the reagents, solutions and standards (reference std., Working std. Primary standards) of the laboratory.
Ensure a correct performance of the OOS / OOE / OOT investigations and deviations that occur in the lab, meeting the established deadlines and defining adequate and robust CAPAs to avoid repeating incidents.
Ensure compliance with the documentation of the labs, approving the SOPs that describe the activities, ensuring compliance with the corresponding training and keeping the documents updated.
Ensure that all analytical tests have been carried out in accordance with current procedures and validated methods.
Identify problems, needs and areas for improvement in the labs. In accordance with this, design, develop and implement projects that allow improvements in quality, safety and performance of the analysis process in the labs.
Find and lead savings and efficiency projects in the labs (LabOpex, Greenlab).
Ensure a development plan for their direct reports that encourages and promotes their evolution and development in the workplace. So, it creates a motivating work environment that promotes the dedication and professional excellence of the team.
Maintain a defined succession plan.
Evaluate and implement new technology and new equipment.
Represent the site with Global QC & AST Chemical Lab.
Member of the SQLT team.
Collaboration with the other departments. Establish good internal and external communication.
What You Need To Bring To The Role
Scientific university degree, eg Chemist, Pharmacist or Science related
Fluent English and Spanish
At least 2 years' experience in a laboratory in industry or equivalent preferable in FDA regulated environment and knowledge in EU and US regulations (GMP, ICH, Pharmacopia).
Team leadership experience
Ability to organize and plan
Commitment To Diversity & InclusionWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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