Validation Associate – Pharmaceutical Manufacturer

Validation Associate – Pharmaceutical Manufacturer (The position has been filled)

• Great Opportunity to Make Your Mark
• Utilise your Prior Experience in QA & Regulatory Complimentary Medicines
• Flexible hours – Full Time or Potential Part-Time Position

 

CLIENT

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.

 

THE ROLE

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

 

SELECTION CRITERIA

• 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

 

APPLICATIONS

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.

 

THANK YOU

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.