Compliance Specialist

Role Description

The Compliance Specialist will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products.

The Compliance Specialist will participate in the compliance program across Laboratory operations.

The Role will require assessment of changes, understanding the regulations and compliance around Laboratory programs. They will be actively involved in investigation and help to implement corrective & preventive actions within the department. The role will be support the Laboratory Operations department during Regulatory, corporate, and Internal audits.

The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.

Role Functions

(Functions include, but are not limited to, the following)

• Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.
• Provide independent quality support, guidance, and expertise to ensure the success of each area
• Support the review & approval of key quality deliverables across Laboratory Operations including Change Control, Deviations, & Safety
• Review & approval of GMP procedures (& associated documents)
• Responsible for Compliance Tier 4
• Supporting archiving for Laboratory Operations
• Participation in inspection of site by CQAC/Regulatory Bodies /third parties.
• Champion the highest quality and compliance standards for the Laboratory Operations
• Makes decisions within guidelines and policies which impact Laboratory Operations
• Champion the highest Quality and Compliance standards for Laboratory Operations
• Participate in GMP walkthroughs to ensure goodhouse keeping & safety standards.

Experience, Knowledge & Skills

• Good analytical and technical skills.
• Demonstrated change management skills (CEM) with continuous improvement.
• Demonstrated use of Leadership Behaviours
• Knowledge and experience in interpreting current applicable regulatory requirements
• Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance.
• Demonstrated ability to drive the completion of tasks.
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
• Proven decision making capability with full accountability and responsibility

Qualifications & Education

• Degree in Science or Quality.