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• Successful pharmaceutical company
• Lane Cove - Parking available
• Very attractive salary package

Our client is a very successful pharmaceutical company based in Lane Cove. They are looking for a Senior Quality Manager to oversee the adherence to the company?s Quality Management System through the application of the quality control processes, the assurance of quality and efficacy and compliance of products to their registrations, marketing authorisation and licensing requirements and be an integral part of the company?s senior management team.

Reporting to the General Manager, your duties will include;

• Primary contact with TGA and other regulatory Bodies with regards to status and compliance of product
• Authorised person to approve, release or reject starting materials and finished products against specifications
• Handling of all product complaints with appropriate corrective actions
• Execution and co-ordination in the event of a product recall
• Review and authorisation of documents to support Quality Management System
• Manage company product risk management programme
• Monitor and control Out of Specifications and use Documented Planned and Corrective Actions to identify failures, root cause and corrective actions to close out deviations to cGMP guidelines
• Evaluate and sign-off Batch Manufacturing Records
• Responsible for compilation, amendments and execution of Validation Master Plan
• Responsible for the compilation, execution and documentation of Stability programme to ICH guidelines
• Internal tracking and monitoring of controlled environments to meet sterile requirements
• Managing current Good Manufacturing Practices guidelines
• Approval and control of all Laboratory Services (internal and external)

You ideally have a suitable scientific or pharmaceutical qualification and have experience in sterile manufacturing (preferably injectables), cGMP compliance, management and control of DCAPA systems, validation requirements and knowledge of analytical and microbiological laboratories and test methods.

You have strong written and verbal communication skills, are confident and decisive in making decisions. You have strong analytical skills and the ability to develop technical documents and write reports. You can also work well under pressure and adhere to principles pertaining to compliance and quality.

You will be rewarded with an attractive salary, annual bonus, free parking and an opportunity to progress your career.

Contact Yvonne Kelly at yvonne.kelly@kissrecruitment.com or call (02) 8904 7400

Kiss Recruitment Australia
Phone: 8904 7400
Fax: 8904 7444
www.kissrecruitment.com

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