Gmp Audits Manager - Third Parties // Gerente De Auditorías De Calidad - Bpm

Detalles de la oferta

Job title : GMP Audits Manager - Third Parties // Gerente de Auditorías de Calidad - BPM Location: Bogotá, Colombia About the job The purpose of this role is to: Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference in patients' daily lives. Main responsibilities: Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organization (CMO). Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications. Ensure compliance to Corporate and Divisional QA requirements and identify and resolve Quality gaps. Responsible for overall quality and safety of products manufactured at those facilities. Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues. Manage supplier audits, ensuring cGMP and SOP alignment. Track market developments and regulatory changes. Follow up on CAPAs. Participate in audits and inspections. Provide an assessment of supplier's quality in place with regards to material compliance. Act as a local quality contact between Suppliers and Global Quality Suppliers. Support audits led by other auditors when specific expertise is needed. Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors. About you Experience: 4+ years of experience in Third Audit Parties. 7-10 years of related experience in the pharmaceutical industry. Thorough knowledge of cGMPs and Code of Federal Regulations in drugs and biologics. Experience in conducting on-site audits and inspections. Thorough knowledge of CAPA systems is required. Experience managing third-party manufacturers and/or contract manufacturer organization is preferred. Required skills: Excellent problem-solving and decision-making skills. Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Master's or Ph.D. in Life Sciences/Healthcare, or related technical field. Languages: Excellent knowledge of English language (spoken and written). Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution. Take good care of yourself and your family, with a wide range of health and wellbeing benefits. Pursue Progress . Discover Extraordinary . At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !#LI-LAT #LI-HYBRID #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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