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Compliance Specialist
Contracting – Brabant Wallon
Compliance Specialist
Job description
- Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics Operations, ensuring compliance with cGMP’s and the company Quality Management System
- Partner with Clinical Supply Compliance Team and management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CPLO. Ensure close interface with QA, CS Compliance and CPLO teams.
- Coordinate and/or participate in the implementation of new regulatory standards within CPLO processes.
- Represent the interests of the CPLO teams, serve in multidisciplinary Compliance project teams, working closely with other team members in a cooperative way to ensure project progression
- Coordinate and/or conduct Quality Standards Gap analysis for the CPLO processes, risk assessment, develop remediation plan and manage tasks to completion.
- Consult and guide the teams in establishment of controls to mitigate compliance risk;
- Oversee the CPLO GMP activities and ensure all employees understand and follow all standard operating procedures.
- Works collaboratively with managers and staff throughout the CPLO organization to provide training, education and promote awareness of and help resolve regulatory and other applicable standards.
- Assist management in the coordination/management of training plans & matrix and ensure compliance with staff qualification standard.
- Participate in the development and implementation of compliance training for all CPLO staff members.
- Provide compliance mentorship and coaching to staff within the CPLO team
- Partner with CS Compliance to coordinate the audit/inspection preparation for CPLO. Timely and suitable Audit preparation (internal, Corporate or by the authorities), execution, support and follow up leading to successful outputs. On the front line during inspections.
- Assist in ensuring inspection readiness, as well as participate in maintaining facility GMP compliance. Conduct self-inspections/housekeeping.
- Analyze internal/external audit and other monitoring results with a view to identifying priorities for the further development of compliance actions.
- Communicate, address and solve problems within own area of expertise as they arise, identifying and implementing innovative solutions to resolve them
- Work closely with CPLO SMEs and QA teams to ensure deviations are adequately managed, according to the quality system guidelines and timely closed. Ensure adequate establishment of the root cause, product impact assessment, corrective and preventive action plan for CPLO. Be the investigation Power User for CPLO.
- Provide support/coaching in quality system programs such as Deviation, CAPA, Change Control.
- Assist management and staff in the writing of quality items such as Deviations, CAPA, Change Control, as well as writing of GMP documents relative to CPLO documentation to ensure compliance with all policies and procedures. Recommend, develop and implement changes to existing and proposed procedures.
- Lead CPLO quality weekly meeting with management, SMEs and QA (Quality items review, SOP periodic reviews, training…). Participate in other CPLO TIER Meetings (QA, Prod...).
- Ensure the management of the life cycle of CPLO logbooks. Perform routine logbook reviews
- Ensure distribution of controlled documents to CPLO (Document distributor role).
- Promote a culture of risk-managed, patient-centered, values-based, high performance and continually improve practice ensuring commitment to quality
- Identify, lead and implement continuous improvement opportunities with the objective to streamline processes, increase productivity and quality (eg. optimization of cycle times, reduction of waste and reworks, improvement of Batch Record RFT….)
- Develop and/or maintain KPI, tracking reports, scorecards, trending and other tools for monitoring the Quality System.
Ensure the daily follow-up of packaging activities:
- In-process controls, start-up & end-of packaging checks, participate in weekly meetings, daily briefings...).
- Serves as the primary on-site point of contact for operators regarding operational matters, ensuring compliance support.
- Refers managerial concerns (e.g., leave, training, conflict resolution) to the line manager for proper follow-up and decision-making.
- Check with the manager to ensure that personnel are adequately trained and informed before performing any critical activities autonomously.
- Inform management of issues encountered during packaging operations.
- Record incidents in the quality system.
- Ensure proper application of procedures (logbook, cleaning, packaging activities...).
- Management and review logbooks
- Distribute controlled documents for the CPLO (Document distributor role).
- Provide support in writing investigations/deviations/CAPA related to packaging and labeling activities.
- Distribute daily team work, monitor actual vs. theoretical throughput rates.
- Participate in TIER meetings (Scheduling, QA, Prod...).
- Participate in improvement initiatives for the Packaging Operations team (housekeeping, 5S, production efficiency, Batch Record Right-First-Time...).
- Review production Batch Records.
- Update performance indicators for the Packaging team.
Profile
- Master’s degree in Sciences
- Fluency in French and English.
- Excellent understanding in GMP related environment : at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality.
- Proven and recognized expert in the field of GMP Compliance.
- Expert dealing with with eCMS, Deviations and investigations.
- Pragmatic mindset, able to propose workable operational solutions complying to regulations.
- Proven ability to provide guidance for improvements and corrective and preventive actions related to quality management system processes
- Ability to lead team discussions and facilitate meetings.
Offer
- Company car
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 or send me your CV, Show emailaddress
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Related categories
Quality (3)