Description
Job Summary:
This Quality Coordinator role involves overseeing and coordinating compliance with technical regulations and Good Practice standards at UPS Healthcare.
Key Highlights:
1. Supervise compliance with applicable local regulations and good practices.
2. Ensure achievement of UPS Healthcare’s quality objectives.
3. Contribute to the company’s competitiveness through new operational proposals.
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**Job Description:**
**QUALITY COORDINATOR**
**EDUCATION:**
Bachelor’s degree in Pharmacy and Biochemistry.
Professional licensure and 24/7 pharmacy management license required.
**TRAINING:**
Proficiency in Microsoft Office at user level.
Experience with Quality Management Systems.
Intermediate English proficiency preferred.
Solid knowledge of GMP, GDP, and GLP.*
Internal Auditor certification.
* *No physical certifications required; these may be provided by the company.*
**EXPERIENCE**
Pharmaceutical Chemist with minimum 3 years’ experience in quality assurance for GMP, GDP, GLP, and/or GMP, and in managing Quality Management Systems in pharmacies and/or laboratories.
**ROLE – PURPOSE**
Oversee and coordinate compliance with Technical Regulations and Good Practice standards across all processes executed at UPS HEALTHCARE.
**FUNCTIONS AND RESPONSIBILITIES:**
This description reflects the essential responsibilities, functions, and competencies of this position. Additional responsibilities and/or duties appropriate to the role may be assigned as deemed necessary.
* Supervise compliance with provisions established in applicable local regulations and based on good practices: GMP/GDP/GLP.
* Supervise that the quality assurance system in receiving, storage, and distribution stages ensures preservation, stability, and quality of pharmaceutical products, medical devices, and health products; and, for controlled products, ensures proper custody.
* Supervise that no contaminated, adulterated, counterfeit, altered, expired, or otherwise unsanitary products or devices are present.
* Supervise data integrity/writing standards in documentation generated during receiving, picking, packaging, and dispatch of products.
* Supervise data integrity/writing standards in documentation generated during product distribution and transportation.
* Ensure achievement of UPS Healthcare’s quality objectives by administering, organizing, and controlling its human, technical, and material resources—ensuring all personnel understand and apply these objectives in their work—and determining the technical strategies required to achieve quality objectives.
* Contribute to the company’s enhanced competitiveness by proposing new operational processes within the warehouse, pursuing quality and consistency across all UPS Healthcare pharmacy processes and operations.
* Maintain a documented Quality System facilitating information flow and communication among different organizational areas and hierarchical levels.
* Coordinate with the Operations department, as appropriate, development of CAPA plans for deviations occurring in operations and/or non-conformities identified during Internal Audits, External Customer Audits, or audits conducted by DIGEMID at UPS HEALTHCARE, and ensure timely implementation of proposed responses and actions per agreed timelines.
* Channel customer complaints for investigation, handling, resolution, root cause analysis, coordination with all personnel involved in the subject process, and issuance of reports detailing corrective and/or preventive actions taken.
* Track implementation of CAPA plan responses per UPS Healthcare procedure deadlines.
* Establish and supervise medium- and long-term corrective and/or preventive actions until causes are eliminated or non-conformities corrected—all related to process, product, and quality system—to prevent recurrence or preclude occurrence.
* Actively participate in updating, developing, and reviewing UPS HEALTHCARE’s Standard Operating Procedures and ensure their implementation.
* Conduct internal audits and/or self-inspections of UPS Healthcare’s Operations area, documenting inspected items and findings.
* Supervise implementation of training, cleaning, risk analysis, and preventive maintenance programs, among others.
* Train UPS HEALTHCARE staff on operational topics, Quality, and data integrity.
* Supervise receiving, storage, and distribution operations for pharmaceutical products and medical devices belonging to customers at UPS Healthcare pharmacy.
* Periodically supervise compliance with activities described in the Cleaning and Sanitization Procedure.
* Actively support development of quality indicators and monthly reporting of results.
* Manage change controls related to matters impacting UPS Healthcare operations. Track implementation until change control closure.
* Support the Quality Department in maintaining and implementing the Quality Management System across UPS Healthcare.
* Perform other tasks assigned by the Technical Director and/or Quality Manager.
* Attend audits.
* Develop, review, and/or approve risk assessments and deviation approvals.
* Approve deviation reports.
* Other duties not specifically listed, as expressly assigned by the employer or direct supervisor.
**WORKING CONDITIONS:**
* Work performed in Punta Hermosa and/or Lurín districts. (Mon–Fri: 8:00 AM–5:48 PM; Sat: 8:30 AM–12:30 PM)
\- Full benefits \- General Regime (CTS, bonuses, vacation, etc.)
* Commuter buses available: From Plaza Norte and VMT/VES/Lurín
* Food card provided: S/150.00
**Employment Type:**
Permanent
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