Your main focus:
- Provide effective Quality leadership and governance within designated areas.
- Manage quality-related affairs specific to the assigned responsibilities.
- Approve pertinent quality documents.
- Ensure daily operations comply with site safety policies and procedures, fostering a culture of safety.
- Conduct ongoing monitoring, encompassing quality systems, on-floor audits, GMP program implementation, and system reviews to ensure operational control.
- Take ownership of quality assurance for products manufactured in the designated area.
- Offer 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 such as 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.
- Reassess and dispose of raw materials, intermediates, and packaging components as necessary.
- Oversee batch disposition, including batch record approval and CoA verification.
- Contribute regulatory insights to relevant documents and processes.
- Monitor GMP compliance, programs, and systems through regular presence in the designated area.
- Participate in site self-inspection programs and conduct audits for compliance with Product Quality Systems.
- Promptly report critical quality issues to appropriate management levels for resolution.
You will need:
- Bachelor's, Master's, or Doctorate in Chemistry, Engineering, or related discipline, with a minimum of 1 year of production or relevant experience.
About the successful candidate:
- 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.
- Excellent interpersonal and communication skills, both written and verbal.
- Demonstrated commitment to continuous improvement.
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.