Quality Assurance Specialist

Há 3 dias


Loures, Lisboa, Portugal Hovione Tempo inteiro

Hovione is a leading Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our innovative technological and productive capabilities set us apart, reaching a top spot in the world market.

We value our people as our main asset for continued success. With over 1950 team members from 36 different nationalities, we are located across Asia, Europe and North America. Our four production sites support our mission of excellence.

We strive for innovation and excellence in everything we do: for our clients, partners and patients. That's why we're In it for life.

Job Responsibilities
  • cGMP Compliance: Ensure project and/or product activities are delivered in compliance with cGMP requirements and maintain the company Quality Management System.
  • Quality Product Key Activities: Manage and participate in key activities for assigned products/projects, including preparation, review and approval of auxiliary documentation, protocols and quality reports.
  • Inspection Readiness: Prepare for and support internal and external site audits and inspections, conducting regular reviews and following-up action plans as necessary.
  • Deviation and Change Control: Periodically follow-up on ongoing deviations and Change Controls to assure timely closure and approval, as appropriate.
  • SOPs and Documentation: Prepare SOPs, department IOPs, quality related reports and change control documents as required and appropriate.
  • Regulatory Coordination: Review regulatory documentation and coordinate site documentation to support regulatory requirements.
  • Equipment Authorization: Authorize the usage of production equipment/utilities when qualification is required.
Requirements
  • Education: University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory).
  • Experience: Educational/training experience in a Chemical environment (desirable).
  • Language: Fluency in English is a requirement.
  • Computer Literacy: Good working knowledge of the MS Office package.
  • Documentation Skills: Good documentation skills and attention to detail.


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