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Validation Associate – Pharmaceutical Manufacturer (The position has been filled)
Australia, New South Wales
Great Opportunity to Make Your Mark
Utilise your Prior Experience in QA & Regulatory Complimentary Medicines
Flexible hours – Full Time or Potential Part-Time Position
Our client is a Herbal Medicines manufacturer established for over 25 years. They are at the forefront of herbal extracts and liquids manufacturing in the contract manufacturing industry and hold a GMP compliant TGA Manufacturing Licence. Their forte is the production of herbal extracts and liquids from single herbs to more complex formulae which are utilised in TGA approved products. Our client is committed to delivering a quality focused, professional service.
This 12 month contract role as Validation Associate is primarily responsible for developing the Validation Master Plan to ensure ongoing quality and compliance to the TGA standard. As part of this, duties will include:
Create required validation protocols and reports, ensuring that these practices are consistent with quality and regulatory standards
Manage the performance of validation activities associated with changes to existing processes, new processes and projects
Prepare, implement and maintain departmental documentation for validation activities and regulatory submissions
Participate and provide technical expertise for Validation during TGA and other regulatory agency inspections
Validation support in authoring or reviewing of various compliance documentation such as deviations, change controls
Manage the validation/qualification of manufacturing equipment, facility and critical utility systems
Support validation/qualification of product, cleaning, shipping and sterilisation cycles
Develop/author and execute URS, IQ, OQ, PQ and other relevant validation life cycle documents
Manage the documentation of SOPs and Deviations
Conduct technical training on process and technology as required by the project
Support audit preparations and defend areas of validation responsibility
Work closely and functionally with multiple departments to schedule and complete all required activities
Conduct the validation/qualification of laboratory equipment
The successful candidate will:
Provide leadership, expertise and management for development of the Validation Master Plan
Translate corporate policies to specific procedures and practices
Have strong knowledge of GMPs and their application
Demonstrate working knowledge of regulatory guideline’s applicable to environmental monitoring skills, equipment/cleaning validation, computer systems and process validation
Demonstrate at least five years previous working experience in a GMP Regulated Environment
B.Sc. degree in Chemistry, Life Sciences or related
Minimum five years working experience in the Pharmaceutical or Complimentary Healthcare Industry, with extensive Validation protocols
It is essential that you are proficient with standard Microsoft Office software, including Word, Excel, PowerPoint.
Strong understanding and commitment to your own safety and that of others.
Proficient at developing and presenting data in a timely and accurate manner.
Demonstrated attention to detail and accuracy along with time management and organisational capacity.
Strong interpersonal skills, with demonstrated commitment to teamwork and collaboration
To apply for this exciting role, please click the ‘Apply Now’ button to submit your application. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria. We require someone to start ASAP so please feel free to call our office on 03 9516 0100 and ask for Daniele to discuss your suitability.
We thank you in advance for taking the time to apply for this role.
Given we receive numerous applications every day, CS Executive Group can only respond to candidates who are being considered for shortlisting. However, should you not receive any follow-up communication from one of our team, please note your contact details and the submitted resume are retained on our ‘Talent Pool’ database allowing our consideration of you in the future when suitable roles arise.