Associate Specialist, Quality Operations

MWI Animal Health; Bogotá ciudad; Híbrido; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

AmerisourceBergen à Bogota recherche un Associate Specialist, Quality Operations pour assurer la conformité locale aux politiques World Courier et améliorer la qualité du service.

Vous coordonnerez les audits internes et externes, gérerez les CAPA et dossiers qualité, suivirez les formations, et soutiendrez la gestion des risques et les changements.

Ce rôle exige une connaissance des systèmes qualité ISO 9001 et GDP, et une expérience en industrie pharmaceutique ou logistique.

Formación

• Niveau de compréhension des processus de gestion de qualité (par ex ISO 9001).
• Expérience de 1 à 2 ans en environnement qualité.
• Bonne connaissance des normes et bonnes pratiques (GxP).

Responsabilidades

• Surveiller et garantir que toutes les politiques et procédures de la société sont suivies par World Courier dans le pays assigné.
• Coordonner les audits internes et externes ainsi que les inspections réglementaires et préparer les documents requis.
• Participer à la gestion des CAPA et au processus de plainte, et soutenir les actions correctives et préventives.
• Enregistrer les données locales pertinentes dans le QA SharePoint et assurer les métriques de qualité à jour.
• Veiller à la conformité des licences et documents réglementaires locaux et communiquer les mises à jour réglementaires.

Conocimientos

Quality Management

GxP expertise

Educación

Degree in pharmaceutical chemist

Descripción del empleo

## Associate Specialist, Quality OperationsPostuler: Bogota, Colombia: Temps Plein: Publié aujourd'hui: R2615970Cherchez-vous à faire une différence dans la vie d’un patient? Chez AmerisourceBergen, vous trouverez une culture innovante et collaborative, axée sur le patient et soucieuse de faire la différence. En tant qu’organisation nous sommes unis par notre responsabilité d’œuvrer pour des vies plus saines. Joignez-vous à nous et postulez dès aujourd’hui!# **Ce que vous ferez**# **Summary of Role:**Under general direction of the Regional Quality Manager plays an important role to assure the local compliance with World Courier policies and procedures. **Responsabilities:*** To monitor and ensure that all Company Policies and Procedures are followed by World Courier the assigned country.* To follow Quality Assurance Policies and Procedures, interpreting and implementing Quality Assurance Standards.* *To coordinate the actions to be taken with other QA representatives belonging to In-country Quality department.** *Ensuring and improving the quality of the service provided to the clients by working close to the operational team.** *To participate in the CAPA and complaint process, including reporting to global QA any deviations or potential problems, participate in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.** *Responsible for coordinating all internal and external audits and regulatory inspections (ISO 9001, ISO 14001, GDP and Client) and coordinating all audit replies. Responsible for preparing all required documents and information to present during External audits and ensuring that a World Courier Confidentiality Agreement has been signed.** *Responsible for quality related activities included but not limited to CDA and Quality Agreements.** *Responsible for reviewing Local Standard Operating Procedures (SOPs) and Work Instructions (WI) to ensure the service standard and qualities are met.** *Establish appropriate training material and conduct training for general quality topics.** *Responsible for subcontractor and supplier qualification in close cooperation with the subject matter expert and the local operational team.** *Assist in setting up and to participate in Risk Management and Change Control processes.** *Enter all local relevant data into QA SharePoint to allow for timely quality metric generation.** *Assist the country in ensuring compliance to World Courier and country specific documentation / retention requirements.** *Serve to assist as first line contact in order to inform the company about regulatory updates that might impact World Courier service.** *Overview calibration, maintenance and qualification program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.** *To identify along with local team, the need of local procedures and implement Local internal guidelines in accordance with operational and technical needs and local regulations, respectively.** *Responsible for quality related activities related to the Self-Inspection Report. (Transport)** *To review the information on the temperature periodic report for all temperature controlled areas. (Transport)** *To support any changes/developments initiated by the Regional /Global Quality Management.** *Any other quality responsibilities assigned by Regional/Global Quality Management.** *Assure that World Courier Depot License(s) as well any other regulatory documentation is/are properly in place and updated. (CSS )** *To contact clients whenever required in order to communicate expansions, depot moving process, regulatory updates clarifications, etc. (CSS)** *To overview that cleaning program is properly implemented and documented. (CSS)** *Communicate to Management team and QA Department, along with Depot and /or Warehouse Manager and Depot Pharmacist, exceptional needs for the storage of products required by clients/ sponsors. To provide local regulation background to support Management and QA team decisions. (CSS)** *To ensure that physical batch packaging records are retained and archived. (CSS)** *Perform that spot checks (as described in WC internal guidelines) to other operative activities are performed in order to monitor that WC procedures and protocol/program instructions are properly performed by depot staff. (CSS)** *To support recalls and mock recalls conducted in the Depot In accordance with applicable internal guidelines. (CSS)** *To act as witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required. (CSS)** *Review deviation assessment which are documented as part of the periodic temperature reporting for all temperature-controlled areas. (CSS)** *Review validation documentation (e.g. MARS, equipment, facility) and to assure that the validation is performed according the Validation Master Plan. (CSS)** *To clarify discrepancies and deviations from SOPs and study / client specific instructions and implement Corrective and Preventative Action Plans in order to correct abnormal procedures (CAPA Complaint Process). (CSS)** *To complete inbound quality checks and confirmation of client’s disposition in approval process for 3PL. (Commercial only)** *To review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines. (Commercial only)** *To maintain the Security Control System -BASC (BOG).** *To act as the Technical Director of the organization in front of the Ministry of Health and its dependencies (Secretaria de Salud).** *To act as the back up of the Technical Director of the organization in front of the Ministry of Health and its dependencies (INVIMA, FNE & Secretaria de Salud).** *To act as the back up of the Technical Director of the organization in front of the Ministry of agriculture and social development and its dependencies (ICA).* .**Education:*** Requires a Degree in pharmaceutical chemist.* *Basic understanding of Quality Management processes (e.g. ISO 9001)** *Basic GxP expertise (e.g. local GMP, GDP and regulatory aspects)** *1 to 2 years working experience in Quality environment.* ***Work Experience:**** *Logistics or Pharmaceutical Industry Experience** 2 years of experience in quality systems support, document management, or a related field required.* Ability to perform routine professional tasks under supervision and deliver accurate work products with audit-ready records.