Key Quality Assurance Role
A key role in ensuring the quality and regulatory compliance of our products is required.
Job Description:
This professional will be part of a cross-functional team, implementing and upholding quality assurance standards.
Responsibilities:
* Develop and Maintain Quality Procedures: Develop and maintain quality procedures, policies, and systems.
* Conduct Routine Inspections: Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
* Collaborate with Teams: Collaborate with teams to ensure quality throughout the manufacturing process.
* Investigate Deviations: Investigate and address deviations, non-conformities, and CAPA to maintain quality.
* Maintain Regulatory Compliance: Ensure compliance with periodic review, change control, deviation, backup, archive, security, and other support processes for systems.
The Ideal Candidate:
* BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
* 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment.
* Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
* Excellent problem-solving and analytical skills.
* Detail-oriented with a strong commitment to maintaining high-quality standards.
* Effective communication and teamwork skills.
This is an exciting opportunity to contribute to our success, with a focus on quality and regulatory compliance.