Requirements: English
Company: Jefferson Wells Belgium
Region: Braine-l''Alleud , Wallonia
Development Lab Quality Ops Partner
Contracting Brabant Wallon
Your responsibilities:
Part of the Development Quality Pharma Operational team, you will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development for:
- 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, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a 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 dev key stakeholders in order to maintain common practices with regards to issued copy within development entities ensuring appropriate application of the issue copy process.
- Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections )
- Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
- Identify, mitigate and subsequently resolve compliance and quality issues that may affect the company development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
- Support QA activities for all Dev QA entities ( Lab, pilot plant,..)
- Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of the company 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 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 (deviation close out / change management/ complaints/ quality improvement).
- Ensure Development Quality Management System directly support Technical Operations and development partner goals and objectives
- Lead the GMP refresher project for CSC and Lab entities
Your profile:
- Masters or bachelors 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 and an ability to interpret current regulations and requirements 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. Output from actions will most likely impact activities across several departments
Our offer:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. Youre interested in this job? We kindly invite you to apply or send me your CV, lena.palmeri@jeffersonwells.be