תיאור תפקיד

Essential Roles and Responsibilities

• Supports and facilitates audits and regulatory inspections.
• Develops, improves, and monitors Quality Systems for the organization.
• Continuously improves areas impacted by deviations and approves appropriate CAPAs.
• Write and revise standard operating procedures (SOPs).
• Provides direction and oversight during active processes and applies understanding of European Union (EU) Veterinary Medicinal Products Regulation and Local authorities (Israel Veterinary Services) regulations related Veterinary Medicinal Products and Continuous improvement.
• Able to independently organize and perform own work tasks and assist coordinating activities to support production schedule thru other co-workers.
• Correct weaknesses, ineffective procedures, policy exceptions and discrepancies and performs or approves appropriate corrective actions followed by effective rates with the aim of being able to offer optimum quality control and quality guarantees.
• Provides Training to new employees.
• Able to work effectively with team members and other professionals such as vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards.
• Proficiency with Microsoft applications, including Word and Excel and environmental systems.

Education and or Work Experience Requirements

• Minimum 6 – 8 years of relevant experience in biotech or pharmaceutical industry
• Advanced knowledge and experience in aseptic processing quality best practices and regulatory requirements.
• Expert level knowledge of GMP regulations, Guidance documents, and industry best practices.
• Prior experience interfacing with and managing inspections performed by regulatory bodies.
• Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, EMA, and ICH

Specialized Knowledge or Skills

• Proficient in quality principles in a manufacturing facility.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude.
• Have good communication skills and able to work in collaboration.
• Effective time management; deliver results on time.
• Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook).
• Has the ability to read, write and communicate in Hebrew and English.