partner cts quality operations and or qp

at  Randstad

JOB DETAILS

summary

• braine-l’alleud
• contract
• 40 hours per week
• group functiontechnics
• referenceCXRSP-112132

job details
We are looking for a Partner CTS Quality Operations and or QP for one of our clients in the pharmaceutical sector based in Braine-l’Alleud.
This is a contract as Consultant (employee or freelance) starting in July 2024 and ending 31th, December 2024 with possible extension.
…
We are looking for a Partner CTS Quality Operations and or QP for one of our clients in the pharmaceutical sector based in Braine-l’Alleud.
This is a contract as Consultant (employee or freelance) starting in July 2024 and ending 31th, December 2024 with possible extension.
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QUALIFICATIONS

As Partner CTS Quality Operatons and or QP, we expect the following competences and skills:

• Bachelor’s degree/ Master’s degree
• Certified auditor by official authorities is an asset
• Eligibility to act as a QP in the EU is essential, with at least five years of practical experience in drug research and development or drug production quality management, including at least one year of drug quality management experience.

• Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)• QA/compliance experience in pharmaceutical regulated environment• Function effectively with minimal supervision • Good teamwork and project management skills. Must have strong, organization and analytical skills.• Must be fluent in English, other languages are a bonus• Facilitator, influencer and planner• Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues• Able to make/ influence quality/compliance decisions in a CMC development environment.Problem solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)• Experience of participation in failure investigations• Familiarity with risk analysis techniquesMAJOR CONTACTSInternal• Interacts with production (Clinical Supply Operation) as the primary QA liaison.• Interacts with Regulatory Affairs• Interaction with Clinical Trials Coordinators• Other QA TeamsExternal• Contract manufacturing

activities and to maintain them in a manner compliant with regulatory and corporate requirements.

• To provide GMP/GDP expertise in the form of Training for members customer departments
• Ensure the CMC review and release related QA activities are consistent across the range of differen

As Partner CTS Quality Operations and or QP your main tasks and responsibilities will be:

• To provide timely and efficient GMP/GDP IMP Release function to all relevant project activities

related to the development of the pipeline projects (included all relevant activities for IMP release: label

approval, batch record documentation, etc…).

• To support compliance with all relevant and appropriate regulations and guidelines, such as those relating

to GMP/GDP, health and safety, etc.

• To participate in the management of QA through active participation in QA forums and other meetings.
• To support the systems and processes in place for the appropriate documentation of our client’s development

activities and to maintain them in a manner compliant with regulatory and corporate requirements.

• To provide GMP/GDP expertise in the form of Training for members customer departments
• Ensure the CMC review and release related QA activities are consistent across the range of different

environments and teams supported (Vendors / Suppliers / in house).

• Proactively support the activities of CMC and Clinical supply QA for relevant manufacturing quality

systems (deviation close out / Change management / complaints / quality improvement).

• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality

of the CMC sections of regulatory submissions.

• Keep current on CMC guidance and apply as appropriate to development processes (ensure that the

accurate and compliant processes are in place).

• To provide support in the evaluation of Temperature excursions for IMP.
• Management of Quality Complaint of IMP
• Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP

activities, including leadership or support to conduct appropriate audits.

• Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
• Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by

editing and reviewing quality agreements

• 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.

• Contribute the preparation of audits (internal/external, regulatory inspections)
• Implement and maintain adequate Quality & Compliance Indicators and communicate results to

appropriate levels of the organization

• Ensure and maintain the adequate accreditation for the packaging facilities (CSO)
• Lead internal audits / Self-Inspections

• Activation of Master Data codes within SAP