Description
Description:Job title: Process Expert Projects CGT
The person would be involved in GCCP project support from PU perspective (qualification support/review, support MS&T activities (document review) ideal background would be biotech engineer with CGT process knowledge and qualification background.
Job Purpose:
Subject matter expert for all process-specific issues to ensure execution of processes on time, continuously improving in quality and productivity, performed in compliance to cGMP, SOPs and applicable guidelines and functional standards.
Supports processes and standards to maintain and improve existing and to implement new innovative concepts and strategies.
Major Accountabilities:
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 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 (i.e. Master Batch Record).
* Support steward for assessment of technical changes and process changes (task manager ACC/PCC)
* Acts as Change Phase Manager
* Supports and performs Quality Risk Assessment
* Ensure that all process changes are managed through appropriate change control procedure.
* Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to e.g. 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, perform root-cause investigations (deviations, complaints, OOS, OOE) and implement effective CAPAs
Validation - for the product(s) assigned:
* Review validation and qualification protocols and reports for technical correctness.
* Support the execution of process validations and qualifications, 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 creating the master manufacturing documents of assigned products, as appropriate.
* Be knowledgeable of process design by providing input during process transfer.
Manufacturing Excellence- for the product(s) assigned:
* Execute process improvements and scale-up.
* Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables
* Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate
Training:
* Support technology trainings and education programs for production operators and others
* Perform on the job training for newly on-boarded associates as needed
* Train process changes as needed in the Production Unit.
* Acts as mentor for Process Experts
Audit SME:
* Acts as Subject Matter Expert for Audits
* Maintain their processes at inspection readiness level
Education/Qualification:
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience.
Experience - Minimum 5-7 years of experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
Languages:
Fluent in Englisch and site local language (German)
- Please add references if candidate already worked at Novartis -