Quality assurance manager
your tasks and responsibilities:
* to transfer and assure the correct interpretation of the compliance management system (cms) of bayer healthcare, previously impacting the site.
* to perform the quality management review (corrective and preventive actions for deviations, trending of complaints product related, counterfeiting, recalls, rejected batches, status of validation master plans, etc).
* to check the changes in the mexican ministry of health law and worldwide regulations (ich, fda, invima, anvisa, tga, etc) to identify the impact on the qms and the actions needed for regulatory compliance.
* to implement all training programs for the qa & qc and distribution center warehouse personnel according to individual necessity.
* to supervise and coordinate the technical documentation needed in the dossiers (national & international).
* to ensure that medical and medicinal devices for human use are of the quality required for their intended use.
* to assure that the dossiers are ready for submission from the technical point of view.
* to guarantee compliance with governmental regulations (national and international).
* to protect our company from economic damage or legal consequences.
who you are:
* bachelor’s degree in pharmaceutical, microbiology, or another similar field.
* at least 5 years of experience in quality systems, gmps, training, product quality review.
* advanced level of english is required.
* other: negotiation skills.
bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity and you have the "passion to innovate" and the "power to change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies, bayer does not accept unsolicited third-party resumes.
bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodations using the contact information below.
application period: january 18 to january 8, 2025
reference code: 836147
division: consumer health
location: mexico: estado de mexico: toluca
functional area: pharmaceutical registration
position level: vs 1.3
employment type: permanent
working time: full time
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