Quality Specialist I

hace 2 meses

Bogotá Cundinamarca, Colombia Thermo Fisher Scientific A tiempo completo

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Provide support to the Quality Assurance area, performing support tasks in the management of different aspects of the Quality System. This to ensure that CTD Andean Region operates within GxP standards.

Responsibilities
- Support the Quality Assurance area with the aim of following both the company's quality policies, based on good manufacturing, distribution and clinical practices, as well as customer requirements.
- Ensure the accurate execution of operational processes as established in the current SOPs.
- Participate in the review of current processes for continuous improvement, Global implementations and drafting and training of SOPs. Fulfill the tasks required for the role of SFLMS and eDMS coordinator.
- Participate in the process of releases/approvals of product for distribution.
- Provide support and review in quality deviation investigation processes.
- Collaborate in the issuance and distribution of local SOPs, updating documents through the eDMS platform and supporting as a facilitator in response to staff queries and doubts.
- Support the review of documentation and reports related to qualification, calibration and validation processes and equipment. Review that the conditions of the third party deposits are within the parameters required by Thermo Fisher Scientific and current standards.
- Support in audit management including conducting of audits and the follow-ups of actions respective to their area.
- Ensure that the Quality records are archived securely and orderly.
- Support the team in the review and approval of the documentation corresponding to the re-labeling process carried out in Third Party Depots.
- Support in supplier qualification processes if applicable.
- Carry out all activities efficiently and safely.
- Assist in other tasks as needed in order to follow the requirements of the Area and the business.

Education
Graduate or about to graduate student of pharmacy or biochemistry.

Languages

Intermediate level in spoken and written English

Skills or Abilities
Customer service orientation and vocation. Highly motivated and proactive. Able to Skills to prioritize multiple tasks according to defined timelines. Excellent communication. Insight, tolerance to frustration, organized, committed. Ability to follow directives and also to use initiative to propose new things.

Internal or external contacts

This position will follow the guidelines established by the QA Supervisor or their delegates. It engages with Facility Manager, Project Coordination and Logistic Operations and Project Management in day to day activities. This to allow the exchange of information regarding deviations, audit/inspection observations, CAPAs, review of documentation and SOPs. Additionally interacts with external GxP related service providers as the needed.

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