.png)
.jpg)
Job Purpose:
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.
- Collect data 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.
- 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.
- Responsible for creating the master manufacturing documents of assigned products, as appropriate
- Be knowledgeable of process design by providing input during process transfer.
- Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
- Support technology trainings and education programs for production operators.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- Minimum 3 years’ experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
The NRL Group connect global companies with the right people to bring engineering projects to life. Supporting contracting companies with energy transition plans and working with our clients to create a cleaner, greener future.
We welcome applications from every walk of life and are committed to diversity within the industries we support, as a certified Inclusive Recruiter and Armed Forces friendly employer. You can ensure you stay safe when job searching online by visiting the JobsAware website.