Deviation Resolution Expert
6 days ago
We are seeking a highly skilled Deviation Resolution Expert to join our team at Resilience. In this role, you will play a key part in ensuring the quality and integrity of our manufacturing processes.
Job DescriptionAs a Deviation Resolution Expert, you will be responsible for writing deviations, participating in Out of Specification analysis investigations, closing batch documentation prior to release, and communicating with internal stakeholders/SME and clients.
You will also act as a point of contact between the manufacturing group, QA/client QA, and regulatory agencies.
- Author deviations, Investigations, Environmental Monitoring Excursion, and CAPA for Manufacturing (USP/DSP/Fill/Finish Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.
- Participate and apply Root Cause Analysis (RCA) tools and ensure CAPAs are implemented to eliminate deviation reoccurrence.
- Work closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.
- Actively participate in regulatory, client, and internal audits by compiling and providing information to department manager.
- Earnestly work on ensuring Deviations are closed within assigned timelines to meet client demand and company targets.
- Contribute in data gathering and analysis for Monthly and Quarterly quality matrix as well as departmental KPI.
- Adhere strictly to GDP, GMP, and safe practices at clinical and commercial scales.
- Implement process improvement-related changes.
- Sure up that corrective and preventative actions that have been implemented are effective via Effectiveness Checks (EC).
- Offer support in ensuring batch readiness action items are completed before batch start.
To be successful in this role, you will need:
- Demonstrate ability to review manufacturing, engineering, and quality documentation.
- Strong working knowledge GMP requirements.
- Experience in top-tier biopharmaceutical environment.
- Knowledge of regulatory agencies HC, FDA and others.
At Resilience, we offer a comprehensive compensation package including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.
Our estimated base salary for this position is $29,750 per year.
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