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Sr. Specialist Inmarket Quality Brazil

2 semanas atrás

Anapolis, Brasil Organon Tempo inteiro

**Job Description**:
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it

1) Ensures that all systems and subsystems relevant to the Distribution Center (includes processes related to receipt (import, transfers), storage and distribution (local market and export)) are under constant supervision, in compliance with GDP and GMP standards and environmental protection established by local and international authorities and established in corporate guides.

2) Monitors and analyzes actions established by other areas or websites, which may have regulatory impact, with survey of relevant points, preventing events involving compliance.

3) Performs evaluation / investigation of deviations related to suppliers, when applicable, Deviations Goiás and direct events involving the operation of the Logistic Operator and / or Logistics ORGANON, responsible for the opening and investigation.

4) Notifies (applicable), monitors and evaluates the CAPAs opened under the responsibility of the Distribution Center.

5) Prepares and/or Reviews Quality Assurance Procedures.

6) Reviews and approves Logistics Procedures and Work Instructions.

7) Performs Walkthrough Audits and supports, when applicable to Systems audits, prepares Internal Audit Reports and coordinates preparatory actions to receive regulatory inspections.

8) Releases Samples of Imported Finished Products.

9) Monitors and executes inventory adjustments (reason and movement valuation, where applicable) via SAP system when applicable.

10) Prepares responses to technical requirements and approval of petition forms, technical reports, regulatory texts for submission to the agency and other documents for which approval by responsible pharmacist is required, with the health agencies;
11) Controls maps of controlled products (Preparation, conference and signature of the RMV, BSPO and MAPS) preparing periodic reports of submission to health authorities at the local and federal level;
12) Coordinates actions related to inventory (includes rejection movements, etc.), through analysis of the planning area;
13) Opens and/or performs tasks related to Change Control with an impact on logistics activities, when necessary and monitor so;
14) Validates, evaluates and prepares, where applicable, documents related to import processes;
15) Analyzes Reports of the Logistic Operator's Supervisory System for monitoring and controlling environmental control data in GMP areas;
16) Trains and notifies employees of the Logistic Operator, where applicable;
17) Reviews Qualification and Validation documents regarding local processes, when applicable;
18) Accompanies market collection process when necessary.

19) Analyzes and handles customer complaints regarding the temperature of the transport tour in the delivery of the product, supporting the Commercial or Logistics area (Customer Service);
20) Monitors and analyzes products for destruction in compliance with current health laws and corporate guides;
21) Evaluates/Reviews/Approves transport monitoring documentation.

(22) accompanies local destruction processes (incineration) of rejected products;
23) Trains and notifies employees of the Logistic Operator in the face of new procedures or their updates, when applicable.

24) Provides technical support for the administration of the Distribution Center SCM system.
- Education Minimum Requirements (languages);
- Bachelor’s degree in chemistry, pharmacy or related science.
- Language: Bilingual (Portuguese and English)
- Required Experience and Skills
- At least 3-5 years of experience in the pharmaceutical manufacturing industry.
- In-depth knowledge of pharmaceutical manufacturing with strong understanding of regulatory requirements (ANVISA)
- Certification and/or demonstrated knowledge in the fields of Quality Auditing, Quality Management
- Preferred Experience and Skills.
- Fully knowledgeable of Brazilian GMP/GDP.
- Experience in importation and distribution of drug products.
- Participation in agency audits is an asset.

**Who we are**

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcar