SEC Recruitment

Process Expert Manufacturing

06 Dec 2018
13 Dec 2018
Contract Type
Process Expert Manufacturing

Location: Shein, Switzerland
Contract Duration: 12 months
Hours: 40 per week

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 cGMP, SOPs and applicable guidelines and normative.

Main Tasks:
• 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 shop floor 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 analyse 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.

Audit support:
• 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
• Must have: pharmaceutical experience
• Desirable: Experience in manufacturing Oral Dosage Forms

Please click the ‘apply’ button to be considered, alternatively please email me directly with a copy of your CV to quoting the job code JB115836

Similar jobs

Similar jobs