Chief of Certifications - Xalapa, México - Bayer

Bayer

Empresa verificada

Xalapa, México

hace 1 semana

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Chief of Certifications

TASKS AND RESPONSIBILITIES

Ensures and executes the compliance release/approval of all finished, semi finished and imported products (Orizaba ownership), as well as the decision of use of starting materials, packaging materials, APIs and excipients used and of maquilas to third parties. Coordinates/assures the excipient review of the manufactured batches. Likewise, approves or rejects customer or administrative returns for all Orizaba owned products.
Manages the system of GMP, OoS, CAPAs and Good Documentation Practices/Data Integrity deviations, Quality Manual and Documentation System. Additionally, ensures the review and approval of all GMP deviations and OoS (out of specification result and trends, during analysis, through the personnel in charge).
Plans and organizes on site quality vigilance in accordance with Good Documentation Practices (GDP), Data Integrity and Good Manufacturing Practices.
Organizes the preparation of master documents for production/packaging (MBR) for paper based hybrid and homogeneous systems to be used in the processes), ensures the archiving and revision of the required master data through the SAP system.
Approves Analysis Procedures, quality specifications of starting and packaging materials and their executable analysis protocols, as well as the operating instructions delegated by the sanitary responsive.
Leads the implementation of global regulations (QMS) issued by the corporate in order to assurance the standard established in the quality system, additionally, leads the issuance and archiving of local regulations (policies, directives, operating procedures, operating instructions, forms and annexes) in such a way as to ensure the content regarding compliance with the Bayer standard and the availability of these documents based on business needs, this through an appropriate document management).

WHO ARE YOU

Education level:
Minimum graduate degree in the pharmaceutical area.

Experiencie:
Minimum 2 years of experience in the pharmaceutical industry or quality system.

Special knowledge:
Change and deviation management, good documentation practices, process inspections, sampling, quality tools, international regulations (e.g.

21 CFR part 210,211, WHO, ICH, ANVISA, INVIMA) ISO (9001,14001,18000,19000,22000,27000,32000), efficient management of documentation files, GMP/GDP QMS system, Word, Excel, PowerPoint, Access, Minitab.

Languages:
Intermediate/advanced English

Período de aplicación: