Overview:
We have an exciting opportunity for a QA Specialist to join an expanding client of ours in the biopharma sector heading into 2025.
Your main focus:
- Offer effective Quality leadership and governance within designated areas.
- Manage quality-related duties specific to the 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.
What you will do:
- 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
Expierence:
- 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.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
