Development Laboratory Quality Operational Partner
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Direct message the job poster from Jefferson Wells Belgium
Your responsibilities:
* The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing.
* The GSP oversight (non-GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK), and the Monheim site (DE).
You will also:
* Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies operates in a fit for purpose and smarter way.
* Provide support to build the end-to-end “issued copy process” for DEV/DSC entities.
* Act as Reconciler by checking the correct completion of the “issued Copy” process.
* Coordinate the development local instructions, liaise with development key stakeholders to maintain common practices regarding the “issued copy” process.
* Provide support during regulatory inspections and quality improvement initiatives, contributing to the preparation of audits (internal/external, regulatory inspections).
* Provide guidance and expert advice to development scientists regarding the appropriate interpretation of national and international GMP regulations and guidelines.
* Identify, mitigate, and resolve compliance and quality issues that may affect the company’s development activities and products.
* Support QA activities for all Dev QA entities (Lab, pilot plant, etc.).
* Maintain and continuously improve Quality systems and processes for the appropriate documentation of the company’s development activities and ensure compliance with regulatory and corporate requirements.
* Partner with QA and CMC Development/DCS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
* Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
* Manage Quality meetings to maintain an adequate level of compliance of the business activities.
* Ensure data integrity and compliance with regulatory requirements and industry best practices.
* Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems.
* Ensure Development Quality Management System directly supports Technical Operations and development partner goals and objectives.
* Lead the GMP refresher project for CSC and Lab entities.
Your profile:
* Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
* Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
* A good understanding of current regulatory requirements and expectations with the ability to interpret current regulations in the product development context is essential.
* QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance, and quality systems is an asset.
* Fluency in French and English.
* Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.
Our offer:
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send your CV to lena.palmeri@jeffersonwells.be
Seniority level
Associate
Employment type
Full-time
Job function
Science
Industries
Pharmaceutical Manufacturing
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