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. The role encompasses oversight of CAPAs, deviations, batch release reviews, and change controls, ensuring compliance and meticulous documentation aligned with regulatory standards. As part of a collaborative and supportive Quality team, you will contribute to maintaining excellence in sterile product manufacturing and quality assurance processes.
Key Responsibilities:
- Deviation and CAPA Management:
- Oversee deviations, CAPAs, and non-conformances within sterile manufacturing facilities.
- Ensure thorough investigation and approval of issues by key stakeholders and management.
- Sterile Manufacturing and GMP Expertise:
- Work within a sterile product GMP manufacturing environment, leveraging knowledge of associated technologies and quality processes.
- Provide guidance on technical procedures, SOPs, GMP requirements, and applicable regulations.
- Risk Analysis and Problem Solving:
- Conduct detailed risk analyses and investigations, applying effective problem-solving techniques and root cause analysis.
- Batch Record and Process Improvement:
- Perform batch record reviews and identify opportunities for process enhancements.
- Auditing and Compliance:
- Execute audits to ensure adherence to quality and regulatory standards.
- Maintain compliance and documentation standards, ensuring alignment with regulatory requirements.
- Technology and Systems Proficiency:
- Utilize Microsoft Office tools, including Word, Excel, PowerPoint, and Visio, as well as electronic documentation systems where applicable.
About You:
- Attention to Detail:
- Exceptional focus on accuracy and thoroughness in all tasks.
- Team Collaboration:
- Proven ability to work effectively in cross-functional teams, fostering strong decision-making and collaboration.
- Critical Thinking and Problem-Solving:
- Proficient in data analysis, critical thinking, and root cause analysis to resolve complex issues.
- Organizational Skills:
- Strong ability to prioritize tasks and meet deadlines in a fast-paced environment.
- Adaptability and Positivity:
- Flexible and resilient, thriving under pressure with a self-motivated and positive outlook.
- Communication Excellence:
- Excellent interpersonal and communication skills, both written and verbal.
- Continuous Improvement:
- 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.
