Job Description
The Quality Systems Compliance Specialist plays a vital role in maintaining and improving the quality management system at our site. This position ensures that objectives are effectively achieved, aligning with compliance requirements to guarantee safety and reliable supply to our customers.
Main Responsibilities:
* Provide quality support to the project and site, including training and guidance on the interpretation and implementation of guidelines/policies and regulatory requirements.
* Focus on specific tasks and roles such as deviation management, change control management, quality systems management, document/SOP management, data integrity management, GMP training & knowledge management.
This role requires strong communication and interpersonal skills to interact with multiple stakeholders. A high level of knowledge in relevant quality and compliance guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) is essential.
Key Requirements
* Motivated individual with over 4 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
* Excellent interpersonal skills: communication, decision making, people influencing skills.
* Able to interact with multiple stakeholders.
* Desire to continuously learn, improve and develop.
* Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.