Job Description
We are seeking a highly skilled QA Specialist to join our expanding client in the biopharma sector.
Main Responsibilities:
* Offer effective Quality leadership and governance within designated areas.
* Manage quality-related duties specific to assigned responsibilities.
* Approve important quality documents.
* Ensure daily operations comply with site safety policies and procedures, and foster a culture of safety.
* Conduct ongoing monitoring, encompassing quality systems, on-floor audits, GMP program implementation, and system reviews to align with operational control.
* Take ownership of quality assurance for products manufactured in the department.
* Provide guidance and mentorship to operations personnel and fellow QA professionals on risk management, facilitating compliant and business-oriented solutions.
Key Tasks:
* Review and approve various GMP documents including standard operating procedures, raw material specifications, and process flow documents.
* Evaluate and approve change controls, deviations, investigations, analytical results, complaints, stability studies, and associated reports.
* Assess and approve qualification and validation documents for facilities, equipment, utilities, methods, and processes.
* Investigate and dispose of raw materials, intermediates, and packaging components as necessary.
* Provide governance to batch disposition, including batch record approval and CoA verification.
* Contribute regulatory insights to relevant documents and processes.
Requirements:
* Bachelor's, Master's, or Doctorate in Chemistry, Engineering, or related discipline, with a minimum of 1 year of production or relevant experience.
* Exceptional attention to detail.
* Proven experience in cross-functional teamwork and decision-making.
* Proficiency in critical thinking, data analysis, problem-solving, and root cause analysis.
* Strong organizational skills with a commitment to task completion.
* Self-motivated, positive attitude, and ability to thrive under pressure.
* Flexible and adaptable to evolving business demands.