Overview
Make a significant impact in the biopharma sector as a QA Specialist.
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.
Responsibilities:
* 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.
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.
Why Us?
* Part of an innovative and growing biopharma company.
* Competitive salary with an attractive shift allowance for 24/7 rotational shifts (7-7 pattern).
* Hands-on experience in a dynamic, collaborative environment.
* Build your career in a role where quality truly makes a difference.