Quality Assurance Consultant (not IT)

Company Description
Ludan Engineering- QA and Validation was founded in 1993, and the QA and Validation department was established in 2005. The company provides Quality Assurance and Validation services to facilities and equipment in the API industry. Services include training, validation support, support to quality assurance, suppliers audits among other services for both start-ups and big companies. Ludan also supports construction and validation issues in areas such as user requirements establishment, clean room design, and equipment and system validation.

Role Description
This is a full-time Quality Assurance Consultant (not IT) role located in Bet Shemesh with flexibility for some remote work. The role requires performing Quality Assurance consulting services, such as writing policy and working procedures and providing support during regulatory authority inspections. The Consultant will also support validation issues.

Qualifications

• Bachelor or Master’s Degree in chemistry, biology or related
• A minimum of 3 years experience in Quality Assurance
• Excellent knowledge of GMP and regulatory requirements
• Experience in working with a regulatory authority such as FDA, MOH, and EU
• Experience in supplier audits, policy writing, and working procedures writing
• Experience in validation requirements such as URS, VMP, PVMP, clean rooms design, construction, and qualification
• Excellent communication and teamwork skills with internal and external stakeholders
• Fluent in English and Hebrew, spoken and written