Overview:
Are you ready to make a significant impact in the biopharma sector? We have an exciting opportunity for a QA Specialist to join our expanding client heading into 2025
Your Main Focus:
- Provide effective Quality leadership and governance within designated areas.
- Manage quality-related responsibilities, ensuring compliance with all regulatory standards.
- Approve critical quality documents and oversee quality assurance processes.
- Promote a strong culture of safety, ensuring daily operations align with site safety policies.
- Conduct on-floor quality audits, GMP implementation, and systems reviews to maintain operational excellence.
- Own quality assurance for department-manufactured products while mentoring operations teams and QA colleagues to drive compliant, risk-based solutions.
What You Will Do:
- Review and approve GMP documents, including SOPs, raw material specifications, and process flow documents.
- Evaluate and approve change controls, deviations, investigations, analytical results, complaints, and stability studies.
- Assess and approve validation documents for facilities, equipment, utilities, methods, and processes.
- Investigate and dispose of raw materials, intermediates, and packaging components as required.
- Govern batch disposition activities, including batch record approvals and CoA verifications.
- Provide regulatory expertise for relevant processes and documentation.
Experience and Skills You Bring:
- Bachelor's, Master's, or Doctorate in Chemistry, Engineering, or related discipline with at least 1 year of production or relevant experience.
- Exceptional attention to detail and strong problem-solving abilities.
- Proven experience in cross-functional teamwork and decision-making.
- Proficiency in data analysis, critical thinking, and root cause analysis.
- Excellent organizational skills and a commitment to completing tasks effectively.
- A positive, self-motivated attitude with the ability to perform under pressure.
- Flexible and adaptable to meet evolving business demands.
Why Join Us?
- Be part of an innovative and growing biopharma company.
- Competitive salary with an attractive shift allowance for 24/7 rotational shifts (7-7 pattern).
- Gain hands-on experience in a dynamic, collaborative environment.
- Build your career in a role where quality truly makes a difference.
Apply Today and take the next step in your Quality Assurance career!
