Manufacturing QA Compliance Analyst
Collins McNicholas
- Co Mayo
- Contract
- Full-time
- Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
- Ensures Aseptic operations are carried out as per Site Procedures.
- Continuously observes the Aseptic technique and behavior of the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up.
- Drives all aspects of Aseptic Performance of the shift team through observation and feedback.
- Drives all aspects of Aseptic performance during sampling and testing.
- Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team.
- Completes real-time review of Batch Record documentation.
- Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms.
- Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions.
- Participates and provides leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures.
- Provides input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing.
- Drives a high-performance Aseptic culture across the site. Actively leads and supports investigations.
- Reviews and Audits Batch Records real-time
- Reviews and Audits Manufacturing and Testing logs as required.
- Completion of Line Clearance activities
- Participate in routine leadership GEMBAs of Manufacturing and Laboratory areas.
- Provides key input to the development and maintenance of the Site Contamination Control Strategy.
- Provides key input to the assessment of EM data and trends.
- Third Level Degree in a Science, Quality or Engineering discipline.
- 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally.
- Strong knowledge of Regulatory Requirements.
- Excellent communication skills.