Validation Engineer - Brisbane - Biotech

Role/Description

• Plan and conduct validation activities including facilities, utilities and equipment validation activities.
• Adhere to Validation Master Plan, including approved procedures, protocols and schedules.
• Assisting with writing project validation plans and write/review SOPs for routine and non-routine tasks.
• Develop protocols and reports (IQ/OQ/PQ) that meet the regulatory requirements and ISO 13485 and cGMP.
• Manage, plan, execute and document all qualification studies for facilities, utilities and new/legacy equipment
• Perform risk assessments on projects and assist in finding resolutions to eradicate or reduce risks.
• Complete all deviations/non-conformances and validation discrepancy documentation
• Maintain validation systems
• Requalification including cold and controlled temperature storage equipment, water purification system, HVAC system, Facility qualification, Reagent dispensing system
• Comply with quality system processes in line with the ISO 9001 and ISO13485.

Requirements

• Hold a relevant tertiary scientific degree
• a minimum 3 to 5 years of industrial experience proven skills or training in a related field
• Experience in facilities, utilities and equipment qualification, including process validation
• Good technical, planning, and operational skills
• Experience and knowledge of GLP/GMP, ISO 9001 or ISO13485 within a quality-controlled production environment
• Demonstrated track record of consistently meeting set objectives.
• Good organisational and interpersonal skills.
• Good verbal and written communication skills.
• Proficient in the use of MS Suite of Software

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY

If you would like to discuss this vacancy further, please call Recruitment Consultant, Rachel Jennings on +61 (0) 2 8310 5846, or email rjennings@i-pharmconsulting.com. If this role is not suitable, Rachel is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS

Senior Quality Assurance Associate, Quality Manager, Quality Director, Senior QA Associate, Senior Quality Systems Associate, Quality Assurance Manager, Quality, MAA, CTA, Labelling, Regulatory Operations, Regulatory Associate, Senior Regulatory Associate, Regulatory Manager, Submissions/Documentation, QMS, CAPA, ISO 13485.