QA Validation Expert.

détails du poste

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détails du poste
For our client, an international company based in Neuchâtel, we are looking for a Quality Assurance Expert – Engineering / Validation.

Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process.


General Information:
 
  • Start date: ASAP
  • End date: 1 year contract
  • Extension: possible, to be discussed
  • Workplace: Neuchâtel
  • Workload: 100%



Tasks and responsibilities:
 
  • Acts as QA representative for both routine GMP activities and company projects.
  • Acts as the Quality partner within Production Unit Team, the Quality Control laboratories, Warehouse and Engineering/Maintenance/Validation departments as applicable.
  • Ensures quality and integrity of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
  • Supports and works in line with the “QA on the shopfloor” requirements (for example through GMP audits or events management).
  • Responsible for quality aspects during the Validation Activities (routine and projects).
  • Shall promote and be involved in Continuous Improvement.
  • Understands and applies company EHS guidelines and commitment policies, takes care of its own safety, reports risk situations and improvement opportunities to supervisory personnel


Your profile:
 
  • At least 2 years of experience in a GMP environment
  • University degree in Engineering, Biotechnology, Pharmacy or Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies
  • Fluent French and a good command of English
  • Demonstrate the company Values of Integrity, Fairness, Honesty, Perseverance as a natural way of working
  • Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards
  • Knowledgeable in auditing and inspection against regulatory / Quality standards
  • Knowledge/Experience with Quality tools such as TrackWise
  • Good analytical skills and ability to simplify the complex
  • Solution oriented and team spirit
  • Good listener and communication skills
  • Good organizational skills and continuous improvement mindset
For our client, an international company based in Neuchâtel, we are looking for a Quality Assurance Expert – Engineering / Validation.

Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process.


General Information:
 
  • Start date: ASAP
  • End date: 1 year contract
  • Extension: possible, to be discussed
  • Workplace: Neuchâtel
  • Workload: 100%



Tasks and responsibilities:
 
  • Acts as QA representative for both routine GMP activities and company projects.
  • Acts as the Quality partner within Production Unit Team, the Quality Control laboratories, Warehouse and Engineering/Maintenance/Validation departments as applicable.
  • Ensures quality and integrity of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
  • Supports and works in line with the “QA on the shopfloor” requirements (for example through GMP audits or events management).
  • Responsible for quality aspects during the Validation Activities (routine and projects).
  • Shall promote and be involved in Continuous Improvement.
  • Understands and applies company EHS guidelines and commitment policies, takes care of its own safety, reports risk situations and improvement opportunities to supervisory personnel


Your profile:
 
  • At least 2 years of experience in a GMP environment
  • University degree in Engineering, Biotechnology, Pharmacy or Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies
  • Fluent French and a good command of English
  • Demonstrate the company Values of Integrity, Fairness, Honesty, Perseverance as a natural way of working
  • Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards
  • Knowledgeable in auditing and inspection against regulatory / Quality standards
  • Knowledge/Experience with Quality tools such as TrackWise
  • Good analytical skills and ability to simplify the complex
  • Solution oriented and team spirit
  • Good listener and communication skills
  • Good organizational skills and continuous improvement mindset

informations de contact.

nous sommes à ta disposition pour toute question.

LS

Luciana Sardo

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