CQV Consultant: Melbourne Pharma & MedDev Projects

PQE Group; Melbourne; On-site; AUD 110,000 - 160,000; Full time

Job summary

PQE Group in Melbourne is seeking a Commissioning, Qualification and Validation (CQV) Consultant to lead HVAC and cleanroom projects in the pharmaceutical and medical device sectors. You will drive URS, DQ, IQ/OQ/PQ activities and ensure GMP compliance across the lifecycle documentation.

Join a global team delivering international projects, with opportunities to collaborate across diverse sites while travelling domestically and abroad as required.

Qualifications

• Bachelor's degree in a relevant field (Pharmacy, Pharma Chemistry, Microbiology, Chemistry or Engineering).
• At least 1 year of relevant work experience.
• GxP industry experience with process and engineering systems/services.
• Good knowledge of cGMP guidelines and data integrity principles.

Responsibilities

• Lead and deliver project objectives, controlling scope to meet budget and schedule.
• Ensure compliance with GMP and QA lifecycle documentation.
• Ensure safe, healthy and secure workplaces for staff and contractors.
• Manage GMP risk and non-compliance risks actively.
• Assist in planning plant shutdowns and co-ordinate activities.
• Develop operational and maintenance manuals and training materials.
• Complete tasks on scope, on budget and on time with zero harm and cash-flow targets.
• Broad experience in HVAC and Cleanrooms Commissioning/Qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ).
• Draft/review Quality Risk Assessments, QMS SOPs, CAPAs and Change Control.

Skills

GxP knowledge

Data integrity principles

Project management

Travel willingness

Education

Bachelor's degree in Pharmacy/Pharma Chemistry/Engineering

Job description

PQE Group in Melbourne is seeking a Commissioning, Qualification and Validation (CQV) Consultant to lead HVAC and cleanroom projects in the pharmaceutical and medical device sectors. You will drive URS, DQ, IQ/OQ/PQ activities and ensure GMP compliance across the lifecycle documentation.

Join a global team delivering international projects, with opportunities to collaborate across diverse sites while travelling domestically and abroad as required.