Auditor in the Quality Assurance Unit

hace 4 semanas


Barcelona, Barcelona, España Anapharm Bioanalytics A tiempo completo

MAIN DUTIES & RESPONSIBILITIES

  • Conduct internal audits (both study specific and Quality System related) and coordinate inspections by external auditors, according to GCP and GLP regulations.
  • Manage and execute corrective and preventive actions (CAPA).
  • Prepare and organize documentation of Quality System (SOPs, forms, training records, etc.).
  • Participate in the validation of computerized systems.
  • Actively support QAU Director in evaluating and implementing new department and Company processes

REQUIRED PROFILE & QUALIFICATIONS

  • BSc or MSc in life sciences, preferably biotechnology, biology or biochemistry.
  • Experience working under GLP and GCP regulations will be greatly valued.
  • Fluent written and spoken English.
  • Proficiency in MS-Office, especially Word and Excel.
  • Knowledge of bioanalytical techniques (LBA, LC-MS/MS) will also be valued.

OTHER REQUIRED SKILLS

  • Good organizational skills and high attention to detail, with the ability to handle multiple tasks effectively and efficiently.
  • Ability to work both autonomously and as part of a team, as required.
  • High level of motivation.

WHAT IS OFFERED

  • Opportunity to work and contribute to the success of an expanding CRO.
  • Solid scientific and QA teams with career growth opportunities.
  • International and multicultural environment in company based in Barcelona.
  • Diligent, professional organization, with a human touch.

Key Responsibilities:

  • Conduct internal audits and coordinate inspections according to GCP and GLP regulations.
  • Manage and execute corrective and preventive actions.
  • Prepare and organize Quality System documentation.
  • Participate in the validation of computerized systems.
  • Support the QAU Director in evaluating and implementing new processes.

Required Qualifications:

  • BSc or MSc in life sciences.
  • Experience working under GLP and GCP regulations.
  • Fluent English and proficiency in MS-Office.
  • Knowledge of bioanalytical techniques.

Desirable Skills:

  • Good organizational skills and attention to detail.
  • Ability to work autonomously and as part of a team.
  • High level of motivation.

What We Offer:

  • Opportunity to work with an expanding CRO.
  • Career growth opportunities in solid scientific and QA teams.
  • International and multicultural environment.
  • Diligent and professional organization.


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