Dev Quality Lab Ops Partner
Contracting – Walloon Brabant
Your responsibilities ?
Part of the Clinical Manufacturing Quality team, the candidate 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).
The Candidate 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 for qualification and validation activities of the different laboratories and production pilots.
- Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections).
- Identify, mitigate and subsequently resolve compliance and quality issues that may affect 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.
- Ensure adequate QA support for the qualification, validation and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories, as well as related cleaning validations.
- Train company personnel regarding cGMP/GSP and QMS requirements related to manufacturing and analytical operations for clinical trials and stability studies.
- Manage Quality Assurance Agreement for New and On-going Supplier.
- Adjust the Level of Quality and associated procedures based on changing regulatory requirements, technical and scientific knowledge.
- Implement and maintain a quality risk management process for the systems used in Development.
- Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of company development activities and ensure compliance with regulatory and corporate requirements.
- Partner with QA and CMC Development/CTS 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 and maintain the adequate accreditation for all laboratories (in /out Braine).
- 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.
- Coordinate the local development process for supplier qualification, maintain the training material associated to it, act as facilitator in order to ease the supplier qualification exercises for development activities, act as enabler and support business partners in order to ease the process, ensure operational qualification of development suppliers. Ensure all information available in the different database are up to date, manage the Change notification from suppliers and coordinate assessments with impacted stakeholders, maintain documentation up to date.
- Coordinate and execute the development management review, ensuring principles mentioned in the associated corporate procedure are fulfilled for development entities.
- Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to internal audit within development entities, coordinate and update the development internal audit schedule, ensuring appropriate application of the audit planning and also manage Self inspections in the Lab.
- Act as Vendor Quality Lead back up for on Quality Oversight.
Your profile ?
- Project Management Skills (tools like MS Project).
- Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packaging and medical devices).
- Strong Communication Skills, including experience leading meetings and coordinating between teams.
- Experience in IT and Automation (networking, IT security, data integrity).
- Autonomy, the ability to manage multiple projects simultaneously under pressure.
- Proficiency in French (essential for communication with production) and English (professional level required for international communication).
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.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]
