Job Title: Quality Assurance Professional
This is an exceptional opportunity for a Quality Assurance professional with a minimum of four years of experience in GMP or sterile environments, particularly in QA line support.
Key Responsibilities:
* Deviation and CAPA Management:
o Oversee deviations, CAPAs, and non-conformances within sterile manufacturing facilities.
o Ensure thorough investigation and approval of issues by key stakeholders and management.
* Sterile Manufacturing and GMP Expertise:
o Work within a sterile product GMP manufacturing environment, leveraging knowledge of associated technologies and quality processes.
o Provide guidance on technical procedures, SOPs, GMP requirements, and applicable regulations.
* Risk Analysis and Problem Solving:
o Conduct detailed risk analyses and investigations, applying effective problem-solving techniques and root cause analysis.
* Batch Record and Process Improvement:
o Perform batch record reviews and identify opportunities for process enhancements.
* Auditing and Compliance:
o Execute audits to ensure adherence to quality and regulatory standards.
o Maintain compliance and documentation standards, ensuring alignment with regulatory requirements.
* Technology and Systems Proficiency:
o Utilize Microsoft Office tools, including Word, Excel, PowerPoint, and Visio, as well as electronic documentation systems where applicable.
About You:
* Attention to Detail:
o Exceptional focus on accuracy and thoroughness in all tasks.
* Team Collaboration:
o Proven ability to work effectively in cross-functional teams, fostering strong decision-making and collaboration.
* Critical Thinking and Problem-Solving:
o Proficient in data analysis, critical thinking, and root cause analysis to resolve complex issues.
* Organizational Skills:
o Strong ability to prioritize tasks and meet deadlines in a fast-paced environment.
* Adaptability and Positivity:
o Flexible and resilient, thriving under pressure with a self-motivated and positive outlook.
* Communication Excellence:
o Excellent interpersonal and communication skills, both written and verbal.
* Continuous Improvement:
o Demonstrated commitment to ongoing personal and professional growth.
Preferred Qualifications:
* Experience in sterile manufacturing environments with a solid understanding of GMP requirements.
* Proficiency in electronic documentation systems and familiarity with quality management tools.
Estimated salary range: £60,000 - £80,000 per annum.