Job Purpose:
Provide front line expert support for all process-specific issues to production within one or more production steps, ensuring execution of processes on-time, continuously improving in quality and productivity, performed in compliance with cGMPs, SOPs, and applicable guidelines and functional standards.
Responsibilities:
* Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with batch instructions and quality requirements.
* Maintain master manufacturing documents of assigned products (e.g., Master Batch Record, Bill of Material & Recipe, Quality Risk Assessment, Zurich Hazard Analysis).
* Ensure critical parameters are within written instruction.
* Manage process changes in assigned products through appropriate change control procedure.
* Create production SOPs and Master Batch Records.
* Act as Subject Matter Expert (SME) for product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and driving process technology innovations.
* Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance, and implementation of CAPAs.
* Evaluate 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.
* Review validation protocols and reports for technical correctness.
* Support execution of process validations and short-term improvement projects, liaising with relevant parties at shop floor to ensure accurate execution.
* Responsible for creating master manufacturing documents of assigned products.
* Be knowledgeable of process design by providing input during process transfer.
* Ensure technical batches generate sufficient process knowledge by thoroughly testing critical variables.
* Support technology trainings and education programs for production operators.
Requirements:
* BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent scientific degree.
* Minimum 3 years' experience in process support role on shop floor of GMP manufacturing and/or QA/QC.
* Proven process understanding (Pharma, GMP, Regulatory aspects).