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 efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.
Tasks and Responsibilities
Shop floor support:
- 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
Validation - execution and review of protocol/report:
- Support the execution of process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution
- Review and assure that validation protocols and report are technically correct
- Ensure protocols are executed as intended
Technical improvement execution:
- Execute process improvements, scale-up
- Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables
Primary packaging closure assessment during changes:
- Evaluate and assure, in case of packaging change, that the primary packaging closure - including materials - are sufficient to ensure stability of the product and do not deteriorate quality
Assure consistency of Master Batch Records:
- Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product
Deviation, Out Of Expectation, Out Of Specification, complaint handling:
- Lead product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification
- Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures
Annual Product Reviews and Product Quality Reviews:
- Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis and for driving process technology innovations
- Be a resource to other departments as Subject Matter Expert for the product and process knowledge
- Provide training for assigned new processes and products
- Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining this position
- Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Desirable MSc. or equivalent experience.
- Fluent in English and proficient in site local language.
- Minimum 3 years experience in process support role on the shopfloor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).