• Validation Associate Jobs in Australia

  • Baxter India Pvt Ltd
  • Australia

Job Description:

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services The companys global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries Baxters employees worldwide are building upon the companys rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care

What Youll Be Doing

POSITION OBJECTIVE

We are currently seeking a Validation Associate for a 12-month Fixed Term contract to join our Old Toongabbie facility The core responsibility of this position is to work closely with our manufacturing stakeholders on validation documentation for the Citect programs to develop SOP, user guides and participation in preparation and writing of Validation Protocol DQ, IQ, OQ, PQ Reporting to the Validation Supervisor ANZ you will be part of QA Validation Team focusing on

Support existing and new System validation activities to meet Computer System Validation requirements and Baxter Corporate requirements
Assist Baxter in its on-going Quality functions prospective and concurrent validation of

Management Information Computerised Systems
Cleaning and Process Validation

POSITION DUTIES

Support Validation of Management Information Systems with regards to Change Control process from initiation through to closure

Prepare User Requirements Specification
Develop System Design Specifications
Develop process flow control diagrams
Write system use, Access Management, Audit Trail Review, Data protection and Backup procedures

Implementation of risk assessments requirements into validation activities
Support risk mitigation processes as part of validation activities
Support validation activities triggered by the legacy review
Participation in preparation and writing of Validation Protocol DQ, IQ, OQ PQ
Co-ordination of execution of qualification activities
Creating and maintenance of Validation Project Plan for projects that need it
Maintenance of validation hard copy file system

Do you have what it takes to build a career here

ESSENTIAL SKILLS AND QUALIFICATIONS

Experience in Computer System Validation
Experience working in a QA team within a Pharmaceutical company
Proficient with Microsoft Office suite (Word, Excel, Power point, Visio)
Engineering degree (Electrical / Mechanical / Computer / Science degree
Knowledge in application of validation methodologies
Demonstrated ability in project management
Demonstrated ability in Technical writing skills
Highly developed verbal and written communication skills
Negotiation skills with ability to operate in a team environment
High level of initiative and energy

Why Baxter

A Career That Matters

Baxters employees are united in a mission to save and sustain lives We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day

Apply today and experience a career that matters! Applications close 3rd August 2018

Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law

Equal Employment Opportunity

Baxter is an equal opportunity employer Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Company
Baxter India Pvt Ltdarfix

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