- The QA Process Support Team Lead will support the weekly and daily production schedules and where required participate in the daily pre-production meetings to review shift production goals and daily post-production meetings to review execution against the shift’s goals.
- Cross train QA Technicians on the various processes to develop personnel and maintain flexibility in ensuring proper coverage.
- Assign daily duties and tasks to team members and ensure proper coverage of all shifts by trained, skilled QA Technicians.
- The QA Process Support Team Lead will act as a resource and collaborator to provide clear, compliant and timely assessments and guidance to production events and problems.
- Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job responsibilities, regulations and procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervisor and other impacted personnel.
- Perform routine review of documentation generated by personnel such as BMRs, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development products for accuracy, completeness, and compliance to GMP and procedural requirements.
- The QA Process Support Team Lead will author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, reports and forms.
- Develop and maintain metrics for trends and key performance indicators where requested.
- Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
- Initiate, facilitate, monitor, trend, Deviations, CAPAs and other Quality System documents as required.
- Support and adhere to established processes and productivity targets.
- Observe established escalation process for issues impacting established production-related SLAs and/or fulfilment of production goals.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
The next QA Process Support Team Lead should have a degree in Life Sciences/Engineering with experience working in a QA function within the pharmaceutical industry. You should have previous experience in a supervisory team lead role and demonstrate excellent communication skills.
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