Process Manager

Summary:

Our client, a global pharmaceutical is currently looking for a Process Manager to join their team at their Cork site on a permanent basis.

As a Process Manager, you would 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, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE).

Responsibilities:

• 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 maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Zurich Hazard Analysis)
• Ensure that all critical parameters are within written Instruction
• Ensure that all process changes in assigned products are managed through appropriate change control procedure.
• Ensure creation of production SOPs and Master Batch Records.
• 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 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.
• Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
• Responsible for creating the master manufacturing documents of assigned products, as appropriate
• Be knowledgeable of process design by providing input during process transfer.

Requirements

• BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
• Minimum 3 year' experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
• Proven process understanding (Pharma, GMP, Regulatory aspects).

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