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Senior validation specialist

Sydney
beBeeValidation
Posted: 14 September
Offer description

Job Opportunity:

We are seeking a skilled Validation Associate to join our team. This is an exciting opportunity for someone who is passionate about ensuring the highest standards of quality and compliance in our facilities.

The ideal candidate will have a strong background in validation principles, excellent analytical skills, and be able to effectively communicate complex information to both technical and non-technical stakeholders.

This role offers a great opportunity for career growth and development, with the chance to work on a variety of projects and contribute to the success of our organization.

We offer a competitive compensation package, comprehensive benefits, and a positive working environment.

About the Role:

The Validation Associate will be responsible for managing validation programs, ensuring the validated state of facilities, utilities, equipment, IT infrastructure, devices, and the compounding process are maintained at all times.

The successful candidate will have a bachelor's degree in a scientific or related discipline, previous experience in a similar or related position, and thorough understanding of validation lifecycle principles.

Key Responsibilities:

* Perform validation activities to maintain compliant status of Processes, Products, Facility, and Equipment
* Maintain Validation Master Plan
* Establish good technical knowledge of the equipment or processes to be validated and associated GMP requirements
* Prepare Validation and Technical protocols and reports as required
* Train staff on validated equipment and processes
* Initiate new and update existing Standard Operating Procedures etc. as required
* Provide technical support to Operations and QA

Requirements:

* Bachelor's Degree in a scientific or related discipline
* Previous experience in a similar or related position (essential)
* Thorough understanding of validation lifecycle principles
* Experience in developing, executing, monitoring, and managing validation activities
* Demonstrated knowledge of qualification and validation and risk analysis requirements within the pharmaceutical industry
* Proven time management skills
* Demonstrated ability to effectively and independently solve problems
* Demonstrated excellent verbal and written communication skills in successfully dealing with customers and difficult situations
* Demonstrated report writing skills

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