This Job Vacancy has Expired!

Junior Quality Assurance Specialist (Biotech/Quality Compliance) -100%

Posted on Aug 28, 2020 by Coopers Group GmbH

Basel, Switzerland
Health Care
Immediate Start
Annual Salary

For our Pharma client in Basel, we are looking for a

Junior Quality Assurance Specialist (Biotech/Quality Compliance) -100%

Main responsibilities:

  • Coordinate and maintain the Documentation programs, to ensure patient safety, product quality, and overall compliance, within the context of a virtual sponsor/business partner environment.

These responsibilities include but are not limited to:

  • Coordinates changes to the applicable Quality System procedures by reviewing changes for applicability, interfacing with internal approval SMEs and management, facilitating functional meetings, and acting as a liaison to bring documentation to closure.

  • Provide basic guidance and training to site users in QS processes.

  • Support in Site inspection preparation and response process.
  • Performs data entries in applicable systems as required to maintain the processes, eg Supplier Management, Compliance Management
  • Advises and responds to queries on quality systems.
  • Records and follows-up on all quality system entries.
  • Coordinates deviations from third-party contractors in the context of manufacturing of APIs, bulk, intermediates, final drug products including quality control, medical devices or transportation.
  • Supports resolving deviations related to product release. Must use scientific judgment to ask key questions during investigations intended to identify root cause of issues.
  • Coordinates and assesses (root cause, impact/risk assessment) product technical complaints, ensure timely completion of the investigation statement in the complaint database.
  • Supports resolving quality problems (root cause investigation) and implementation of CAPAs. Tracks timely closure of CAPAs.
  • Adhere to all GMP requirements.

Required Experience and qualifications:

  • Master's degree in science or equivalent is required; Biology/Chemistry preferred, with 1-3 years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience.
  • Experience in Quality Assurance functions and Quality Compliance functions preferred.
  • Good written and verbal communication skills required.
  • Must be fluent in English. Other languages a plus.
  • Scientific writing experience preferred.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Strong customer service philosophy required.

Reference: 937022361

Set up alerts to get notified of new vacancies.