Job Description

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Senior Quality Validation Specialist- IT

Advertiser: Evolve Scientific RecruitmentMore jobs from this company

Job Information

Job Listing Date
7 Dec 2018
Location
Melbourne, Eastern Suburbs
Work Type
Contract/Temp
Classification
Science & Technology, Chemistry & Physics

Senior Quality Validation Specialist- IT

  • Global analytical laboratory
  • 3 month contract with the view to go on longer
  • Eastern Suburbs of Melbourne
About the company:

This is a global pharmaceutical laboratory that provides analytical services to clients. This company requires the assistance of Evolve Scientific Recruitment to source an experienced Senior Validation Specialist-IT that has specialised in computer system configuration and validation on laboratory instruments.
Based at their state of the art facility in the Eastern suburbs it has a great work culture and commitment to supporting its people.

About the role:

We are currently seeking a Quality Validation Specialist-IT who displays initiative and is self-motivated. This role is a 3 month contract with the view to potentially go on longer
Reporting to the Manufacturing Quality Manager, your key responsibilities will include:

· Perform validation on computer systems (FDA 21 CFR Part 11, PIC/S PE-009-13 Annex 11 Computerised Systems)
· Review computer systems, software and validations
· Review and creation of computer system and security validation documents
· Creating validation protocols, reports and quality procedures
· Implementing continuous improvements, CAPA and quality risk management systems
· Liase with vendors, IT and process owners to formulate solutions and configure systems in line with cGMP

To be successful in this position you will have:

· Tertiary qualifications in Science preferably in Chemistry with experience in IT software and lifecycle knowledge.
· Proficient in computer system validation and data integrity requirements
· Experience working in a cGMP regulated contract testing laboratory or system auditor
· Expertise with 21 CFT Part 11 and GAMP standards for validation of automated systems will be an advantage.


How to Apply:

Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Note: Applications only accepted from Australian / NZ residents with valid Australian work rights or temporary residents on work visas e.g. Working Holiday Visa.

Need more information:

Please call Dr Aphrodite Anastasiadis-Pool, Cathy Mercuri or Deborah Cusmano on 9040 1630

How to Register with Evolve:
For upcoming positions please click on the "Apply Now button. By applying to any of our roles you will also be registered for future positions unless you request not to be.

Why Evolve Scientific Recruitment?
Evolve is an award winning agency specialising in scientific/technical recruitment in: Pharmaceutical, Food, Biotechnology, Chemical, Petrochemical, Environmental, Health Services, Life Sciences, Mining and more.
Melbourne | Sydney | Adelaide | Brisbane

www.evolvescientific.com.au | 1300 918 995

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About the company:

This is a global pharmaceutical laboratory that provides analytical services to clients. This company requires the assistance of Evolve Scientific Recruitment to source an experienced Senior Validation Specialist-IT that has specialised in computer system configuration and validation on laboratory instruments.
Based at their state of the art facility in the Eastern suburbs it has a great work culture and commitment to supporting its people.

About the role:

We are currently seeking a Quality Validation Specialist-IT who displays initiative and is self-motivated. This role is a 3 month contract with the view to potentially go on longer
Reporting to the Manufacturing Quality Manager, your key responsibilities will include:

· Perform validation on computer systems (FDA 21 CFR Part 11, PIC/S PE-009-13 Annex 11 Computerised Systems)
· Review computer systems, software and validations
· Review and creation of computer system and security validation documents
· Creating validation protocols, reports and quality procedures
· Implementing continuous improvements, CAPA and quality risk management systems
· Liase with vendors, IT and process owners to formulate solutions and configure systems in line with cGMP

To be successful in this position you will have:

· Tertiary qualifications in Science preferably in Chemistry with experience in IT software and lifecycle knowledge.
· Proficient in computer system validation and data integrity requirements
· Experience working in a cGMP regulated contract testing laboratory or system auditor
· Expertise with 21 CFT Part 11 and GAMP standards for validation of automated systems will be an advantage.


How to Apply:

Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted / not processed). Note: Applications only accepted from Australian / NZ residents with valid Australian work rights or temporary residents on work visas e.g. Working Holiday Visa.

Need more information:

Please call Dr Aphrodite Anastasiadis-Pool, Cathy Mercuri or Deborah Cusmano on 9040 1630

How to Register with Evolve:
For upcoming positions please click on the "Apply Now button. By applying to any of our roles you will also be registered for future positions unless you request not to be.

Why Evolve Scientific Recruitment?
Evolve is an award winning agency specialising in scientific/technical recruitment in: Pharmaceutical, Food, Biotechnology, Chemical, Petrochemical, Environmental, Health Services, Life Sciences, Mining and more.

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