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**Laboratory Systems**TASKS AND RESPONSIBILITIES1.
Design and ensure the life cycle of analytical documentation as Quality Specifications, Test Procedures for starting materials (APIs and excipients), packaging materials and dug products for internal use and for Regulatory submission, including the References for critical materials used in manufacturing/analytical processes according to current requirements, on the other hand ensure the availability of analytical dossiers for Regulatory purposes within the required periods and according to the needs of the Business.2.
Lead GMP and improvement projects in Quality Control that are common to both Physicochemical and Microbiological Labs to optimize processes and/or implement improvements or regulatory requirements, guaranteeing or carrying out the relevant GMP documents (ERU, ER, EF, DIA, Change Controls, etc.).3.
Guarantee the monitoring and evaluation of new or changes of compendial chapters (International and national pharmacopoeias) in order to inform to involved functions and support the implementation in Quality control areas.4.
Guarantee the evaluation of analytical data with the purpose of detecting improvements in analytical/production processes and monitoring the key performance indicators of Quality Control to guarantee the follow-up and grant the systematically compliance on the other hand coordinate the attention of drug product complaints (received by Quality Management).5.
Manage common areasof Quality Control (such as retention samples, document and solvent storage) as well as support in the planning of analytical activities and management of analytical supplies on the other hand provide analytical support to other areas of QualityControl through having personnel trained in analytical activities, in case of absence or workload.6.
Ensure that basic regulations of Quality System "QMS" (Policies, SOPs, Operational Instructions, etc.)
applicable to general Quality control topics are evaluated, updated and disclosed as well as to perform new required regulations or support in this topic to other Quality Control areas.7.
Guarantee the compliance of quality sub-systems (deviations, changes, CAPAs, complaints,OoS/OoT results) according to current procedures, documenting on time and following the established flows in the regulations.8.
Comply and guarantee the compliance with current quality, analytical safety, environmental impact and occupational hygiene standards, as well as attend and guarantee the attention of scheduled courses related to GMP, HSE, with the aim of promoting, through their knowledge, the continuous improvement of the activities carried out in their work area.
Additionally, participate and develop activities or projects of the Management or the Site, when required and the necessary applicable skills and training are available.WHO ARE YOU**Education level**: Bachelor degree Profesion: Pharmaceutics (Pharmaceutical Chemist Biologist or related).
**Experiencie**:Min