GMP Compliance Coordinator

Basic qualifications:

Third level science-based degree.

Preferred qualifications:

Third level science-based degree.

Details:

Scope of Responsibility

Key member of the Quality Systems team responsible for:

  • Process owner for L1 and L2 audit programme, and successful implementation of same on site.
  • Support Management Review/Quality Council.
  • Support Quality Audits Level 1, 2, 3 and 4 Inspection Readiness activity
  • Support CAPA Process and Quality Alert Process
  • Quality metrics
  • Familiar with Regulations (Medicinal and Medical Device)
  • Site Recall/PIRC procedure
  • Internal Halal Auditor
  • Supports site TIP projects as required
  • Continuous improvement in Quality team processes
  • Procedures review and approval
  • Quality Representative support to other departments
  • QMS Implementation support
  • Risk Management (support identified risks as required)

Impact of role on business objectives

Medicinal and Medical Device Value Streams

Environmental Health & Safety (EHS) Responsibilities

  • Perform duties in a compliant manner and behave in accordance with site SOP's, GSK EHS standards and guidelines and relevant legal requirements
  • Read and understand Standard Operation Procedures applicable to role
  • Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
  • Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
  • Be aware of the impact of your job activities on EHS issues
  • Ensure all engineering changes made have safety considerations and best practices as core attributes.
  • Ensure basis of safety files are available and up to date for processes.

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
  • Awareness of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device's for required markets; As below

i. Medical Device guidelines

ii. QMS GSK Policies and Procedures

iii. Pharmaceutical Affairs Law Japan

iv. EU GMP guidelines

  • 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 GSK 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
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products / markets.

Basic Experience

2 years experience in pharmaceutical / healthcare industry preferably in a similar role.

Preferred Experience

  • Understanding of and ability to implement continuous improvement projects.
  • Ability to communicate with a wide variety of people at all levels both within the sites and GSK and externally through appropriate skills: - Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.
  • Familiarization with products manufactured in all Value Streams.
  • Thorough knowledge of site quality systems.
  • Demonstrated ability to problem solve.
  • Demonstrated ability to effectively plan work and to manage projects.

Expected level of application of Knowledge Understanding of Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets.

Contact information:

You may apply for this position online by selecting the Apply now button.

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