qa compliance specialist a POMEZIA

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tipo di contratto
somministrazione
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pubblicato
luogo di lavoro
pomezia, lazio
categoria
Tecnici specializzati, qualità
sottocategoria
Qualità
tipo di contratto
somministrazione
riferimento
CX151070
offerta proposta da
gruppojj@randstad.it

descrizione

For a multinational company in the chemical-pharmaceutical field, we are looking for a QA Compliance Specialist.

The position

  • oversights and execute Quality Management Systems and compliance in DC location (internal and/or 3PL) within the corresponding country for MD, Pharma and Consumer sectors.
  • supports Deliver country operational team on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.
  • implements departmental strategies and services as the business expert on quality systems, distribution, and quality management. 
  • supports and execute the optimization of the quality systems and processes and ensures alignment with the worldwide business, applicable local regulations and Enterprise standards, the quality vision and/or Policy, and provides a measurable impact to quality, cost, and customer value. 
  • identifies opportunities to continuously improve quality, cost and time factors, consistent with both Segment and Deliver business objective
  • Identifies significant business issues, prioritize for action, and support improvement opportunities and problem solutions. 
  • maintains understanding and awareness of current and emerging regulations and the impact to quality and distribution practices. The position executes quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

 

responsabilità

Key Responsabilities:

  • Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities (e.g. receiving, pick, pack, lot reconciliation) 
  • Responsible for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the Distribution Centers
  • Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
  • Overseeing repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC 
  • Responsible for validation of temperature controlled (cold chain and controlled ambient) facilities 
  • Responsible for accurate and timely communication of temperature control excursions occurring within the DC to appropriate partner. 
  • Responsible for the investigation of temperature control excursions and subsequent remediation activities
  • Support for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, other.
  • Support for the successful management of inspections
  • Supports for establishing Quality Agreements with, qualifying of, and Q&C management of distribution, logistics, and material suppliers.

 

competenze

Main features required: 

  • Degree in the scientific area (Pharmacy, Chemistry and pharmaceutical technologies, Biomedical Engineering)
  • Experience in Quality, QC, Ops or regulatory affairs of medicinal products, cosmetics, food supplements or medical devices
  • Knowledge and experience with quality systems (e.g. Pharma, DIN EN ISO 13485, 9001)
  • Excellent level of spoken and written Italian and English
  • Knowledge of IT Tools (Trackwise) is a plus.

We offer a time determined contract with the possibility of both personal and professional growth, with a contractual level to be defined based on the candidate's real skills.

Work area: Pomezia (RM)

livello di studio

Laurea specialistica o a ciclo unico
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