Logistics Quality Analyst (CLAR - PT213) Santiago, Chile
Role Description
Logistics Quality is responsible for the final disposition of the imported products received into Chile. This process includes the inspection of the products (incoming inspection – analysis of documents, Certificate of Analysis, Labels, lots, expiry date), analysis of the information of temperature and others.
The position is responsible for the elaboration of SOPs and support to Quality Management System in Chile, performing trainings to SCL and Affiliate colleagues as well as to LSP.
Products that need special handling conditions (i.e.: cryogenic) are inspected by this position to ensure the proper control of storage and distribution.
Some products imported to Chile are supplied in labels with artworks that do not comply with Chile regulations. Therefore these products have to be labeled reconditioned in LSP and the process has to be supervised and final lot disposition performed by Zoetis Quality.
Quality oversight of the LSP is performed by this position, conducting external audits/ routine inspections at LSP to assess the compliance to Good Distribution Practices and Zoetis Quality Standards. Quality deviations are evaluated by Logistics Quality, being responsible for CAPA follow-up.
Responsibilities:
- Audits and Inspections:
- Participate in local Agencies Inspections and GQCA audits in the LSPs on Product Quality & GMP aspects.
- Perform Quality inspections at the Logistic Service Provider Warehouses
- Oversight of LSP
- Quality Agreements with LSPs and contractors providing GMP services to Supply Chain
- Warehousing, Transportation and Distribution :
- Temperature readings/filing from Dataloggers review and approval
- Temperature and Relative Humidity (if applicable) excursions investigations
- Deviations related to Transportation and Distribution/Returned Goods Management/Cold Chain Management
- Reconditioning activity :
- Creation of Technical specifications/Master batch records for relabeling activities
- Creation of packaging specifications, testing and release of packaging materials
- Ensure correct Labeling is used for reconditioning activities
- Quality oversight for re-packing and relabeling operations
- Deviation management for relabeling activities
- Relabeling Batch Record Review
- Product release:
- Independent Management of lot status in Zoetis inventory system in compliance with local regulations
- Local Batch Release
- Product return:
- Inspect and disposition returned goods from the market
- Assist Affiliate lead in market action activities
- Certifications:
- Review local government certification (where applicable- example Bios need to be tested and released by local regulatory authority)
- Review certifications for export of products from multiple markets
- Quality culture at LSP:
- Ensure LSP has appropriate SOPs for activities
- Ensure alignment with local Affiliate Quality leader (Regulatory)
Qualifications
Education:
- University degree in Chemical Pharmacist, Veterinarian, Biology or other related areas.
- Advance Proficiency in English
Experience:
- Minimum 3+ years experience in similar positions and responsibilities.
- Experience with internal control audits and policies are required.
- Experience in the use of SAP and SUN system.
- Proficiency in Excel.
- Experience in the Animal Health or Pharmaceutical industry considered a plus.
- Knowledge of current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Pharmaceutical/Veterinary legislation and regulations
Skills:
- Strong analytical and organizational skills, with strategic thinking capabilities and attention to detail.
- Ability to manage confidential information.
- Continuous improvement focused.
- Ability to multi-task and meeting deadlines on multiple projects and activities.
- Ability to communicate effectively with all levels of management (both verbally and in writing).
- Comfortable working in a fast-paced, high-energy environment.