| Quality person in plant (PIP) Philadelphia, PA (Onsite) at Philadelphia, Pennsylvania, USA |
| Email: yogesh@stellentit.com |
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From: Yogesh Sharma, StellentIT yogesh@stellentit.com Reply to: yogesh@stellentit.com Quality person in plant (PIP) Philadelphia, PA (Onsite) Phone + Skype Job description: CDMO experience essential Key responsibilities listed below: Assess the Finished Drug Product facility in Northeast Philadelphia for compliance with cGMP and industry best practices. Monitor onsite operational activities related to Quality culture, including material readiness, equipment setup, line interventions, in-process checks, manual visual inspection, data verification, and inventory tracking. Identify and communicate risks or issues observed during operations, such as documentation practices, adherence to procedures, escalation handling, segregation of potential issues, and data integrity. Conduct 100% batch record reviews to ensure compliance with Good Documentation Practices (GDP) and verify calculations. Review SOPs and batch records in relation to observed operational and maintenance activities to identify opportunities for process improvements. Support issue triage and investigations, escalating when necessary to involve subject matter experts and management. Provide daily summary reports detailing observations, recognition of good practices, and identification of risks or opportunities. Analyze observations to identify recurring trends and themes to support continuous improvement efforts. Keywords: Pennsylvania Quality person in plant (PIP) Philadelphia, PA (Onsite) yogesh@stellentit.com |
| yogesh@stellentit.com View All |
| 03:36 AM 02-Apr-25 |