Spring Life Sciences is looking for it's clients, leader in the pharmaceutical industry a: Your Mission:
Act as primary point of contact for all compliance topics for the Operation team.
Ensure that production documentation as batch record, raw data are reviewed according to the GMP requirements and corrected prior to transfer to QA.
Ensure that all deviations and change request are tracked and correctly completed according procedures.
Support if necessary the establishment of change control documentation and investigation report.
Support the redaction of GMP documents as product record, procedures, reports.
Support to establish a set of KPI to track the Compliance level of the Production activities (deviation and change management, operators training follow-up....).
Participate to ensure that GMP rules are correctly applied during all manufacturing activities (on the field reviews, documentation reviews, discussion, internal audit, documents update...).
Review production documentation as appropriate, to ensure proper alignment with GMP rules.
Communicate with production teams to explain and foster compliance in daily activities. If necessary, manage training on general GMP rules.
Support for the preparation of the health authorities and internal audits.
Support for the follow-up of the CAPA plan issued after internal or health authority audits.
Lead and participate to all committees related to release activities and make the link with production team and activities.
Support the Integration QA systems.
1-3 years in Biotech manufacturing or quality.
Knowledge of GMP and regulation linked with the Biotech manufacturing.
High level of independence in his thinking and problem-solving activities.
Decision-making ability and high sense of responsibility.
Capacity for innovation.
Ability to work under pressure and handle challenging situations.
High communication skills.
Fluent English (spoken and written).
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