Auditor in the Quality Assurance Unit
hace 4 semanas
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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