דרושים בתחום רפואה ובריאות

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide.
An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.
Due to a constant growth, we are currently looking for a Pharmaceutical Consultant to join our team in Israel.
In this full-time role, the Consultant will provide validation services for our clients.
Responsibilities include, but are not limited to, the following:
· Collaboration in project teams
· Various roles in the validation process including the creation and execution of qualification protocols (IQ, OQ, PQ),
· Development of validation plans
· Performance of risk assessments.
· In addition, this role requires close interaction with clients and the ability to work and communicate with both team members and external stakeholders.

Requirements:
· 1/2 year of experience in pharmaceutical environment
· Knowledge of Computer System Validation and GxP
· Degree in Technical Degree (Engineering, Chemistry, Informatics, Physics, Mathematics)
· Fluent English (at least B2/C1 Level)
· Full availability to Travel up to 75% - local

Mandatory:
• 7+ years of experience in QA/RA positions.
• Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971..
• Proven experience with regulatory submissions including FDA and obtaining regulatory approvals/clearances.
• Verbal and technical writing skills.
Advantageous:
• Familiar with MDR requirements.
• Qualification and experience as an internal auditor
• Experience and understanding of IEC 60601, IEC 62304 and software development lifecycle.
Education:
• Bachelors Degree required (preferably in a engineering or bilogical field) or equivalent in work experience.
Required Skills, Knowledge and Characteristics:
• Highly motivated, committed and responsible.