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Quality Assurance Specialist

4 weeks ago

Sunshine Coast, Australia Boehunter Full time

**Location**:Sunshine Coast, Queensland

**Position Overview**:We are seeking a highly motivated and
highest quality standards, and adhere to established validation and compliance processes. This position requires a deep understanding of GMP principles, quality systems, and the ability to work within a skilled team of quality professionals.

**Key Responsibilities**:
**1. Validation and Compliance Oversight**:
Support the development and maintain the validation master plan for the GMP facility, including equipment, processes, and systems.

Ensure compliance with all relevant regulatory standards, including TGA and ODC and other applicable agencies.

Support the development and execution of validation protocols and reports, including IQ, OQ, and PQ.

Collaborate with cross-functional teams to ensure that all validation and compliance activities are carried out efficiently and according to established procedures.

Review and release the batches for sale according to current federal and local regulations and orders.

**2. Quality Assurance System Management**:
Establish and maintain a comprehensive quality assurance system that covers all aspects of GMP operations.

Implement and maintain quality assurance policies and procedures to drive a culture of quality within the facility.

Conduct regular internal and external audits to ensure compliance with quality standards and regulatory requirements.

Identify and address quality issues through root cause analysis, deviations, and CAPA (Corrective and Preventive Actions).

Create and update SOPs to comply with regulations and meet business decisions.

**3. Team and Development**:
Support, Mentor, and provide guidance to a team of quality professionals where required.

Foster a collaborative and proactive working environment within the quality assurance team.

Ensure effective communication and collaboration with other departments, including production, engineering, and regulatory affairs.

Present weekly reports to management where required.

**4. Documentation and Record Keeping**:
Maintain accurate and up-to-date documentation related to validation, compliance, and quality assurance activities.

Support to Develop and oversee the document control system to ensure that all records are easily accessible and in compliance with regulatory requirements.

**5. Continuous Improvement**:
Continuously assess and improve quality systems and processes to enhance efficiency and effectiveness.

Proactively identify areas for improvement and drive initiatives to optimize quality practices.

Stay updated on industry best practices, regulatory changes, and emerging trends in GMP to ensure the facility remains in compliance.

**Qualifications**:

- Bachelor's degree in a relevant scientific or engineering field; advanced degree is a plus.
- Minimum of 4 years of experience in quality assurance, validation, and compliance in a

GMP environment.
- Strong knowledge of GMP regulations, quality management systems, and validation

Principles and team skills.
- Exceptional problem-solving and decision-making abilities.
- Strong communication and interpersonal skills.
- Regulatory affairs experience is a plus.

**Benefits**:

- Competitive salary commensurate with experience.
- Opportunity for professional growth and development in a dynamic and growing

organization.
- A supportive and collaborative work environment that values teamwork, innovation,

and excellence.

Join our team and be part of our mission to provide safe, effective, and high-quality medical cannabis treatments to patients in need.

**Job Types**: Full-time, Permanent

**Salary**: Up to $95,000.00 per year

Work Authorisation:

- Australia (preferred)

Work Location: In person