Senior Validation Manager

4 days ago

Melbourne, Victoria, Australia beBeeGmp Full time $90,000 - $125,000

Regulatory Compliance Specialist

Key Responsibilities:

- Develop and implement validation protocols and reports for equipment, utilities, and facilities to ensure adherence to Good Manufacturing Practice standards.

- Manage the qualification process for new and existing equipment, utilities, and facilities to guarantee compliance with GMP guidelines.

- Support quality investigations and deviations, identifying and implementing corrective actions to maintain GMP compliance.

- Ensure adherence to GMP guidelines for document control and record-keeping.

- Develop and implement training programs for GMP compliance and validation activities.

- Provide guidance and support to other departments to ensure GMP compliance.

- Collaborate with cross-functional teams to develop and implement new validation strategies and methodologies.

Qualifications and Experience:

- Bachelor's degree in engineering or science-related field.

- Minimum of 5 years of experience in Good Manufacturing Practice (GMP) validation activities.

- In-depth knowledge of GMP guidelines and regulations.

- Essential experience with Ebeam technology.

- Strong analytical and problem-solving skills.

- Excellent communication and interpersonal skills.

- Ability to work independently and as part of a team.

- Relevant certifications such as American Society for Quality (ASQ), Project Management Professional (PMP), or Six Sigma are desirable.

We are seeking an experienced Regulatory Compliance Specialist to join our organization. If you have the required experience and qualifications, please submit your resume and cover letter for consideration.

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