Computer Systems Validation Consultant
5 months ago
Leading Melbourne based medical/pharma company with a global presence
- Work with a diverse group of Scientists, Project Managers and QA professionals
- Long term contract where you can create your own footprint within the company.
**The Company**:
Melbourne based consulting company that delivers a multitude of solutions across best-practice advice, training, software solutions and contract labour resources to pharmaceutical, medical device and life science industry.
**The Role**:
- Be actively involved in performing Computer Systems Validation activities as according to the Master Validation Plan, OECD Principles of GLP, ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements.
- Create, update and/or review validation documents (eg user requirements, test plans, IQ/OQ/PQ tests, UAT, reports, spreadsheet validation)
- Facilitate and conduct functional risk assessments
- Writing and reviewing validation documentation that meet regulations and requirements, including change management activities
- Organise, participate and oversee testing as required
- Ensure the validation of computerised systems and spreadsheets are supported and managed through the lifecycle.
**Skills and Experiences**:
- Experience in validation, quality management and documentation for multiple systems including LIMS within regulated environments.
- Excellent knowledge of IT hardware and software, including Windows Server and Desktop OS.
- Good understanding of regulations and guidance applicable to computerised systems.
- Excellent organisational, time-management and communication skills
- Strong analytical and problem-solving capabilities with the ability to perform root cause analysis.
- An understanding that teamwork is the path to achieving outstanding results in a fast-paced commercial work environment.
-
Computer Systems Validation Associate
2 months ago
Melbourne, Australia Icon Group Full time**Pharmaceutical Compounding** **Melbourne** **Full Time** **Slade Health** **Computer Systems Validation Associate - Slade Health** - Join a Dynamic and Supportive Work Environment - Work in a Fast-Paced Environment that Demonstrates Compassionate, Genuine Care for Patients and Customers - Permanent Full-Time Position - Located at any of our existing...
-
Computer Systems Validation Specialist
2 weeks ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob Title: Computer Systems Validation SpecialistThe Computer Systems Validation Specialist at PSC Biotech Corporation will be responsible for planning, writing, implementing, and reviewing validation protocols for computer-based systems. The specialist ensures computer-based systems operate as intended and meet regulatory requirements. Key responsibilities...
-
Validating Computer Systems Specialist
1 week ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob DescriptionThe PSC Biotech Corporation is seeking a Validating Computer Systems Specialist to join our team. As a key member of our organization, you will play a crucial role in ensuring the integrity and professionalism of our products and services.About the RoleWe are looking for a highly skilled and experienced Validating Computer Systems Specialist...
-
Computer Systems Validation Specialist
4 weeks ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob DescriptionThe Computer Systems Validation Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. This role will ensure that computer-based systems operate as intended and meet regulatory requirements.Duties and Responsibilities:Write, review, and approve validation...
-
Computer Systems Validation Expert
4 days ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob OverviewThe PSC Biotech Corporation is seeking a skilled Computer Systems Validation Engineer to join their team for a 12-month contract. This role will be based in Australia, and the successful candidate must have full working rights.About the RoleThis exciting opportunity involves planning, writing, implementing, and reviewing validation protocols for...
-
Computer Systems Validation Engineer
4 months ago
Melbourne, Australia PSC Biotech Corporation Full timeJob Description The Computer Systems Validation Engineer (CSV) will be responsible for assisting in planning, writing, implementing, and reviewing validation protocols for computer-based systems. The person is responsible for making sure computer-based systems are operating as intended and meet regulatory requirements. The incumbent is also responsible...
-
Computer System Validation
6 months ago
Melbourne, Australia PQE Australia Pty Ltd Full time**About the business and the role** We are a service provider company, leader in the **Pharmaceutical and Medical Device sectors** since 1998, with **more than 2000 employees, 45+ nationalities and 32 offices all over the world (Europe, Asia and the Americas).** Joining PQE means being a part of a multicultural and challenging company, with many local and...
-
Computer Systems Validation Expert
5 days ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob OverviewPSC Biotech Corporation is seeking a highly skilled Computer Systems Validation Engineer to join our team on a 12-month contract starting September 2024. This role requires full working rights for Australia.
-
Chief Computer Systems Validation Specialist
2 weeks ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob OverviewThe PSC Biotech Corporation is seeking a skilled Chief Computer Systems Validation Specialist to join our team. As a key member of our validation department, you will play a vital role in ensuring the integrity and professionalism of our products and services.About the RoleThis 12-month contract position offers an estimated salary of $120,000 -...
-
Senior Validation Specialist
1 week ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeAt PSC Biotech Corporation, we are seeking a highly skilled and experienced Senior Validation Specialist to join our team. This is a 12-month contract opportunity that offers a competitive salary of AU$95,000 per annum.About the RoleThe successful candidate will be responsible for assisting in planning, writing, implementing, and reviewing validation...
-
Clinical Support Consultant
5 months ago
Melbourne, Australia Harris Computer Systems Full timeAbout Harris Maternity Harris Maternity is made up of a portfolio of clinical software solutions that support maternity. Our portfolio has been born through four acquisitions of best-of-breed maternity software providers, including K2 Medical Systems, Meridian Health Informatics, MCATS and Ternity Group. Our products range from digital maternity records to...
-
Computer Network
2 months ago
Melbourne, Australia Mansys Pty Ltd Full timeWe are Mansys Pty Ltd, recruitment consultants. Our client, Osan Ability Assist, is actively looking for a Computer Network and Systems Engineer to join its team on a full-time basis at Melbourne. The business is a NDIS Service provider. The Computer Network & Systems Engineer will be responsible for planning, developing, testing and optimising the IT...
-
Validation Manager
5 months ago
Melbourne, Australia Moderna Full time**The Role**: Reporting to the Director, Engineering & Facilities, the Validation Manager will own the site Commissioning, Qualification and Validation (CQV) program and will be the SME for site qualification activities. This role will own the delivery of the site re-qualification and periodic review programs, ensuring systems and equipment remain in an...
-
Validation Analyst
6 months ago
Melbourne, Australia Bell People Consultants Full timeGlobal Pharmaceutical Organisation - Long Term Contract Opportunity - Melbourne Metro - Hybrid Role - WFH & Office Based **About The Company** Operating as a major global Multinational pharmaceutical manufacturer with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace,...
-
Senior Validation Specialist
7 days ago
Melbourne, Victoria, Australia PSC Biotech Corporation Full timeJob DescriptionThe Computer Systems Validation Engineer will be responsible for planning, writing, implementing, and reviewing validation protocols for computer-based systems to ensure they operate as intended and meet regulatory requirements.Duties and ResponsibilitiesDevelop and review validation procedures, documents, test scripts, and final reports in...
-
Digital Systems Consultant
4 weeks ago
Melbourne, Victoria, Australia BlueRock Full timeJob SummaryWe are seeking a highly skilled Senior Consultant to join our team at BlueRock Digital. As a Senior Consultant, you will work closely with clients to develop and implement operational strategies, with a focus on business systems implementation and integration.Key ResponsibilitiesDeploy and configure complex systems to meet client needs.Perform...
-
Computer Systems Administrator
3 weeks ago
Melbourne, Victoria, Australia FourQuarters Recruitment Full timeJob Title: {title}About the Role:We are seeking a highly skilled Computer Systems Administrator to join our team at {company}. As a key member of our IT department, you will be responsible for managing and maintaining our computer systems, ensuring they are running smoothly and efficiently.Main Responsibilities:Maintain and troubleshoot computer systems,...
-
Validation Associate
4 weeks ago
Melbourne, Victoria, Australia Evolve Scientific Full timeAbout Evolve Scientific:We are a global pharmaceutical company that supplies healthcare products to the Australian and International markets.Our company is located close to Melbourne CBD and is seeking a Validation Associate to join our team on a 6-month contract.This position is suited to candidates with a Science or engineering background and experience...
-
Validation Associate
1 month ago
Melbourne, Victoria, Australia Evolve Scientific Full timeAbout Evolve Scientific:We are a global pharmaceutical company supplying healthcare products to the Australian and International markets.This role is located close to Melbourne CBD and is a 6-month contract opportunity.We are seeking a Validation Associate to join our team, ideally with a Science or engineering background and experience with equipment and...
-
Strategic Business Systems Consultant
4 days ago
Melbourne, Victoria, Australia BlueRock Full timeAbout BlueRock DigitalWe are a dynamic consultancy that specialises in intelligent digital strategy, custom development, and systems consulting and implementation.Our mission is to build a highly integrated community of exceptional minds who can work together to challenge industry norms and drive meaningful growth and efficiencies for businesses.Job...