Quality Systems Manager-Perm-Waterford | Collins McNicholas

Quality Systems Manager-Perm-Waterford

  • Reference: CJ44417y
  • Job Type: Permanent
  • Location: Cork, Tipperary, Waterford
  • Category: Science, Pharmaceutical & Food

Quality Systems Manager – Pharmaceutical

Responsibilities

  • Responsible for the following processes and ensuring the requirements detailed below are delivered by the Quality Systems Team (ref: GQP 2101 Addendum 1: Organisation, Personnel Management and Training: GMS Manufacturing Sites):
  • Change Control: review and approval for process, product and facility change proposals, including trending and assessment of impact of changes over time
  • Technical Terms of Supply (TTS): development, review and approval of Quality Agreements; review and approval of changes, and assessment of deviations and trends
  • Approval of distribution risk assessments to assure compliance with cGMP
  • Complaints: review and approval of complaints; coordination of complaints programme and trending of complaints
  • Inspection Readiness
  • Ensure Inspection readiness every day
  • Lead auditor for L2 audits
  • Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting
  • Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits, including audit readiness assessments. Responsible for external communications during L3/L4 audits
  • Manages audit follow-up, including participating in root cause analysis (where required), reviewing and agreeing CAPA plan and monitoring CAPA effectiveness
  • Building capability of L1 Auditors
  • Regulatory Compliance: provides a point of contact to a regulatory advice service or performs that service to ensure that manufacture and supply is compliant with the registration detail in all markets supplied
  • QMS Champion
  • Principle point of contact between Central QMS Team and site/functional leadership teams to ensure QMS updates are appropriately communicated and actioned
  • Implementation and maintenance of QMS on site, with site subject matter experts
  • Maintenance of site procedure system
  • Facilitation of Gap Analysis driven by updates of GQPs, GQMPs and GQGs
  • Reporting gap closure action plan updates for Quality Council and escalating significant risks associated with QMS implementation and adherence
  • To ensure local audit processes confirm QMS “in place and in use”
  • Supplier Quality monitoring and improvement
  • Risk Management
  • Documentation Compliance
  • Quality performance measurement and Quality Council process
  • Quality budget and headcount adherence
  • Ensures QS team complete all training requirements
  • Manages Quality Systems team (Appraisals, etc.)
  • Continuous improvement in Quality team processes
  • Continuous improvement in RFT/compliance
  • Designate for Quality Director
  • Supports site GPS projects

Halal Assurance System implementation

  • Internal Halal Auditor
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products/markets
  • Sit as a member of the Halal Management Team

Management Representative

  • Ensuring that process needed for the QMS are established, implemented and maintained
  • Reporting to Senior Management on the performance of the Quality Management System and any need for improvement
  • Ensuring the promotion of awareness of regulatory and customer requirements throughout the site
  • Liaising with relevant Regulatory Bodies E.g. Notified Body and Competent Authority Impact of role on business objectives
  • Role operates at Management Level for both Medicinal and Medical Device Value Streams

 

Quality Responsibilities

  • Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements
  • Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to
  • Maintain GMP standards where appropriate to your role
  • Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
  • Management Policies relevant to your job role
  • Attend training and complete assessments as required
  • Ensure Quality and GMP are at the forefront of changes proposed
  • Ensure Inspection Readiness Every day
  • Identify and co-ordinate the activities and resources to prepare for the Inspection of the site.
  • Identify and agree Site/Facility Inspection Readiness Team members and their roles and responsibilities
  • Maintain and assemble information relating to prior commitments, required documentation, and Regulatory intelligence and site/facility issues
  • Communicate inspection readiness status to local stakeholders.
  • Ensure assessment learning’s are addressed and all outstanding issues and risks are identified and managed.
  • Escalate any risks to maintaining and achieving inspection readiness in required timeline
  • Understanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinals for required markets; As below

i. MDD (93/42/ EEC)

ii. ISO 13485: 2012 and ISO 13485:2003

iii. QMS company Policies and Procedures

iv. EU GMP

v. Pharmaceutical Affairs Law Japan

vi. MHLW Ordinance No 169

vii. MHLW Ordinance No 179

viii. MHLW Ordinance No 2

ix. cGMP (CFR 210/211, 820)

  • Understanding of Japanese Quality Requirements and Working Relations
  • Ability to provide key input into Quality management decisions
  • Ability to effectively lead, develop and motivate the QS team
  • Understanding of and ability to implement GPS initiatives
  • Ability to communicate with a wide variety of people at all levels both within the sites and company and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.
  • Demonstrated ability to problem solve
  • Demonstrated ability to effectively plan work and to manage projects

People Management Responsibilities

  • GMP and Regulatory Compliance, Quality teams’ performance, Quality Systems departments on both sites, Suppliers, Health Product Regulatory Authority (HPRA) and SGS.
  • Recruit suitable candidates as required.
  • Effectively manage and develop talent of employees

Qualification & Requirements

  • Third level science-based degree (preferably post graduate).
  • Preferred Education Diploma in Pharmaceutical Manufacturing Technology (Qualified Person course) is preferable.
  • 3 – 5 years’ experience in a pharmaceutical / healthcare industry in a Quality management capacity
  • LMLS – Green Belt
  • Understanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinals for required markets;
  • Understanding of Japanese Quality Requirements and Working Relations
  • Ability to provide key input into Quality management decisions as management team member.
  • Ability to effectively lead, develop and motivate the QS team
  • Understanding of and ability to implement GPS initiatives
  • Ability to communicate with a wide variety of people at all levels both within the sites and company and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.
  • Demonstrated ability to effectively plan work and to manage projects

For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email rory.walsh@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Rory Walsh

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  • Rory Walsh
  • Cork Regional Manager
  • 021 4809118
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