Sr Project Lead and GMP Compliance Specialist
XDES is specialist in recruitment van technisch personeel. Job Description
The Sr. Project Lead and GMP Compliance Specialist is part of the Support team within DSO (Drug Substance Operation) department, in the organization, and reports to the Support Team manager. In this role you ensure that the department stays in compliance with the Good Manufacturing Practices (GMP) as well as the adherence to company procedures and policies, and reports non-conformances and changes into QEM (Quality Event Management) systems. You interact with DSO stakeholders and work in close collaboration with the rest of the Support Team, as well as with the Operational Teams.
The department Drug Substance Operations (DSO) is an international team of about 50 people working on the manufacture of clinical vaccine batches (phase I to III), cell banks, virus seeds and development activities to support the development of new vaccines. The department consists currently of five teams all with their own responsibilities: Lab Support, Preparations, Cell culture and Downstream processing and a Support team. Production is performed under strict cGMP regulations.
Responsibilities:
Leads, performs and supports internal/departmental audits, and collaborates with QA and inspection authorities to facilitate external audits as needed;Identifies and eliminates compliance risks, including performing departmental compliance self-inspections;Leads, supports and identifies compliance improvements for DSO department, including documentational updates or creations;Reports any non-conformance through ETS system, leads Quality Investigations and Change Controls including Root Cause Analysis;Monitors progress and confirms effectiveness of Corrective /Preventive Actions plans and Correction records;Supports and advice the department on compliance related topics;Provides compliance awareness and annual cGMP trainings as needed, coaching and guiding of other employees on best practices;Escalates extraordinary situations through the appropriate communication lines;Supports GGB/QDB addressing compliance issues and risks;Supports supplier changes through the appropriate communication lines;Reviews quarterly environmental monitoring trend reports;Single point of contact for coordinating/supervising contractors and/or third-party service suppliers.
Job RequirementsMinimum HBO level, WO level preferred;Minimum 4 years relevant experience;Knowledge of GMP guidelines and previous experience in GMP environment is a must;Proficient in written and oral English is a must (Dutch is a plus);Skilled in FMEA risk assessment;Experience with leading non-conformances/Quality Issues;Strong problem-solving and Root Cause Analysis (i.e. Fishbone, Pareto, Kepner-Tregoe) skills;Experience with document updates. Knowledge of TruVault electronic documentation management system is a plus;Experience with change controls. Knowledge of TrackWise global change control management system is a plus;Project leading skills required;Lean methodology knowledge and/or experience preferred;cGMP gowning experience preferred;You have excellent communication skills, a quality and compliance mindset, you show senior behavior (i.e. accountability, leading by example, open communication, blame free);Remote working may be a possibility upon discussion and approval from management.
Salary and BenefitsThis is a responsible job with good employment conditions.Contact UsContactpersoon voor deze functie als Sr Project Lead and GMP Compliance Specialist is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: joost@xdes.nl Kenmerk: 10879.
