Ensures compliance to external and internal regulations / guidelines (Q/EHS).
Responsible for maintaining & improving Quality Management System within the IPT.
Responsible for guiding internal and external inspections/audits.
Continuously analysing current performance to find and lead improvements
Products/Results Key activities
- Translates new regulations and corporate requirements (gap analysis) to IPT implementation plans.
- Support implementation of strategy
- Acts as 1st contact person to global EHS / GMP organization.
- Support IPT or COE in developing & performing operational compliance tasks (EHS and cGMP) and improvement projects.
- Manages overview of (new) compliance improvement projects (global) and new policies and assures timely execution via TIER4 priority setting.
- Monitors actual operational EHS/GMP compliance within IPT/COE and takes action if required (go to Gemba).
- Ensure working according to guidelines; under take immediate actions to solve issues.
- Advice IPT lead in case of non-compliances; show courage and candor and act independently and autonomous.
- Develop and report compliance related KPI's (incl. deviations, incidents / capa's etc.).
- Maintains overview of all IPT related permits and documents and related
- Participate in EHS/GMP global improvement / implementation projects
- Develop improvement proposals by using Lean 6-Sigma tools.
- Is departmental representative in various meetings as described in EHS
management system and various departmental handbooks.
- Reviews internal documents as SME.
- Is change owner for compliance (non-processes) related changes.
- Responsible for internal recurring GMP / EHS routine meetings, coordination and execution of departmental audits.
- Support improvement engineers with GMP/EHS knowledge and the implementation.
- Has a direct link to IPT counterpart and Q/EHS representatives in order to
harmonize the way of working across the IPT's.
- Prepares and coordinates all necessary activities required for internal (incl.
global) and external compliance inspections/audits.
- Represents department during inspections.
- Contributes from compliance point of view to Pre-Approval Inspections.
- Ensures that observations found during inspections are reported, timely solved (action plans) and closed.
- Responsible for governance/coordination of internal (IPT) inspection rounds.
- Ensures that new regulations / guidelines (GMP/EHS) are effectively
communicated and trained to all IPT members.
- Analyses deviations/observations from inspections / go to gemba
observations etc. and suggest improvements.
- Local QMS owner
- Ensure compliance and timely updates of procedures, monitor timelines for drafting, reviewing and authorizing procedures.
- Ensure procedures are aligned (not conflicting with other procedures) within and outside the IPT/COE (gatekeeper within IPT/COE)
- Acts as DBO expert within the IPT. Trains DBO authors within the IPT/COE.
- Owner of the Documentation Responsibility Matrix (approval + authorization).
- Gives input to Validation Master Plan (VMP) & Validation Summary report (VCR)
- Author for GMP WI/Manuals
- Coordinate, perform and ensure actual RIE's in IPT/COE
- Perform rout cause investigations of small incidents and unsafe situations within IPT/COE
- Perform risk analysis and TRA's; support line management by high risk work activities.
- Ensure GMO permits are up-to-date and operate as an expert in the IPT during the application of GMO permits of new processes.
- Participate in investigation teams in case of major incidents
- EHS Expert within IPT/COE, safe work procedures, corporate guidelines and regulations
- Is consulted for changes in processes, equipment and investment projects (EHS assessments).
- Manages continuous improvement projects from AVP (Afdelings Verbeter
- Ensures compliance to VMS (Vergunningen Management Systeem)
- Ensures compliance to Environmental Permit.
- Acts as a Biosafety coordinator within IPT, working together with the local Biosafety Officer
- Chair AAM meetings IPT/CoE and support AAM members
- Author for EHS WI/Manuals
- Continuous focus on quality and safety compliance
- Go to Gemba
- Advices IPT lead
- Make problems visible & strive for Continuous Improvement
- Strong advisory skills.
- Helicopter view over multiple IPTs; link impact of improvements or non-compliance issues to other IPT.
- Pro-actively identify knowledge gaps and propose additional training to IPT lead and/or employee development officer.
- Execute and/ or participation outside IPT as:
- Lead or member of (MPS) improvement projects related to EHS/GMP compliance
- Participation in audit and inspection (preparation) teams
- Act as SME during risk analyses like HAZOPs, FMEA, PRIE and root cause analysis
Client and/or regulatory inspectors (EHS/GMP)
EHS experts or consultants (arbodienst)
Global EHS / Quality
Everybody within IPT
Progressive Recruitment is gespecialiseerd in de bemiddeling van professionals binnen de sectoren IT, Global Energy & Natural Recources, Life Sciences, Supply Chain en Engineering. Wij kunnen je helpen bij je zoektocht naar een tijdelijke opdracht, maar ook als je zoekt naar een permanente functie in deze sectoren. Kijk voor meer informatie op www.progressiverecruitment.com of www.progressivege.com
Progressive Recruitment is specialized in recruiting professionals in the sectors IT, Global Energy & Natural Recources, Life Sciences, Supply Chain and Engineering. We can help you find temporary and permanent job opportunities in these industries. For more information, visit www.progressiverecruitment.com or www.progressivege.com.