North Carolina All, NC
Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and productivity, per-formed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE).
Stewardship for the product(s) assigned:
Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
Responsible for revisions to the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Hazard Analysis)
Ensure that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, and Validation Protocol).
Support steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
Ensure that all process changes in assigned products are managed through appropriate change control procedure.
Ensure creation of production SOPs and revisions to Master Batch Records and/or Electronic Records (MES).
Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
Support data collection for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
Support product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
Maintain processes at inspection readiness level.
Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate. Validation for the product(s) assigned:
Review validation protocols and reports for technical correctness.
Support the execution of process validations, and short term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution. Launch & Transfer for the product(s) assigned:
Responsible for revisions to the master manufacturing documents of assigned products, as appropriate.
Responsible for reviewing Manufacturing Electronic records for Operations.
Technical knowledge transfer (through training)
Complete Tech Transfers on-time
Batch release on time/in quality
Batch record RFT
Line throughput time
Number of Deviations
PpK/CpK process capability
OoS, OoE Out of Specification, Out of Expectation process-related
Customer Complaints process-related
Number of Recalls process-related
Success rate of internal audits and Health Authorities' inspections
Fluent in written and spoken English 3 years experience in process support role on the shop floor of a GMP manufacturing and/or QA/QC preferred Proven process understanding (Pharma, GMP, Regulatory aspects) Process Excellence Green Belt or Black Belt trained and Black Belt Certified (preferred). Process Validation experience and/or knowledge
|Bachelor s Degree (preferred) in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy; or 10 years of experience in GxP regulated environment preferred. Master s Degree in science preferred|