Quality Ops Partner

Il y a 5 mois

Brainel'Alleud, Belgique Jefferson Wells Temps plein

Location:
**Braine-l'Alleud**
**#23611**

**Quality Ops Partner**
Contracting - Brabant Wallon

Our partner is currently looking for a **Quality Ops Partner **to join its team. This international company is well-known for its pharmaceuticals.

**What are your responsibilities?**

You will be part of the Development Quality Pharma Operational team and will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development by:

- Driving 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.
- Providing support to build the end to end “issued copy process’ for DEV/DSC entities.
- Acting as Reconciler by checking the correct completion of the “issued Copy” process
- Providing support during regulatory inspections, and quality improvement initiatives.
- You will contribute the preparation of audits (internal/external, regulatory inspections)
- Providing 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 internal development activities and products.
- Supporting QA activities for all Dev QA entities ( Lab, pilot plant,..)
- Maintaining and continuously improving Quality systems and processes in place for the appropriate documentation of internal development activities and ensure compliance with regulatory and corporate requirements.
- Implementing and maintaining adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
- Managing Quality meetings to maintain adequate level of compliance of the business activities.
- Ensuring 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).
- Ensuring Development Quality Management System directly support Technical Operations and development partner goals and objectives.

**Who are you?**
- You hold a 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 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.
- Good written/oral communication in English
- Ability to work autonomously for the assigned activities with limited supervision
- 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 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.

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