Overview
We are seeking a talented QA Specialist to join our team and make a significant impact in the biopharma sector.
Your primary focus will be on providing effective Quality leadership and governance within designated areas, ensuring compliance with all regulatory standards.
Main Responsibilities:
* Manage quality-related responsibilities, including the review and approval of critical quality documents.
* Oversee quality assurance processes, promoting a strong culture of safety and ensuring daily operations align with site safety policies.
* Conduct on-floor quality audits, GMP implementation, and systems reviews to maintain operational excellence.
* Owning quality assurance for department-manufactured products, mentoring operations teams and QA colleagues to drive compliant, risk-based solutions.
Key Tasks:
* 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.
* Govern batch disposition activities, including batch record approvals and CoA verifications.
* Provide regulatory expertise for relevant processes and documentation.
Requirements:
* 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.
About Us:
As a member of our team, you will have the opportunity to work in a dynamic, collaborative environment, gaining hands-on experience and building your career in a role where quality truly makes a difference.
What We Offer:
* Competitive salary with an attractive shift allowance for 24/7 rotational shifts (7-7 pattern).
* A chance to be part of an innovative and growing biopharma company.
* The opportunity to take the next step in your Quality Assurance career.