QC Analyst x2

Basic qualifications:

Basic Education

Educated to primary or higher degree level-Chemistry or associated science.

Basic Experience

2-3years experience in a pharmaceutical / healthcare industry.

Preferred qualifications:

Preferred Education

Third level science-based degree (preferably post graduate).

Preferred Experience

Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately, e.g.:

  • cGMP (CFR 210/211)
  • MDD (93/42/ EEC)
  • ISO 13485: 2003
  • EN ISO 13485: 2012
  • QMS GSK Policies and Procedures
  • EU GMP
  • Pharmaceutical Affairs Law Japan
  • MHLW Ordinance No 169
  • MHLW Ordinance No 179
  • MHLW Ordinance No 2
  • CFR 820
  • GSK Facility & Technical Process Guides

Understanding of relevant regulatory requirements for all markets.

Understanding of quality systems for OC and OTC.

Knowledge of all products and manufacturing processes for OC & OTC.

Details:

Job Purpose:

  • Analysis of Raw Material, Intermediate, Stability samples and/or Finished Products.
  • Other duties may be assigned on discretionary basis as required by new developments or changes to the role.

Scope of Responsibility

  • Permit and Promote only desirable activities and behaviours.
  • Sampling and testing activities carried out for the specified QC team in line with GLP and business targets.
  • Achieves Lead-time targets (and proactively addresses barriers to achievement)
  • Ensures full EHS compliance in QC activities
  • Ensures full GLP compliance in QC activities
  • Ensures QC documentation and team activities relating to M-ERP/LIMS is in compliance.
  • Facilitates improvements in QC processes
  • Meets CAPA and other site metrics
  • Completes On-The-Job Training process & training record
  • Supports PPR and other site processes
  • Supports site GPS projects

Impact of role on business objectives

  • Ensure QC team work in a safe manner and in accordance with GxP
  • Training of QC team for specific tasks in accordance with GxP
  • Decision-making and liaison with internal departments in order to gather information in order to disposition product in accordance with GMP
  • Liaison with corporate colleagues as required to resolve issues
  • Highlighting issues to the Quality Control Manager, OQ Manager and Quality Director as appropriate
  • Reviewing completed analytical reports prior to OQ approval.
  • Preparation and review of in-house procedures (SOPs)
  • Troubleshooting analytical problems
  • Scheduling in-house functions to ensure that the QC team operates as efficiently as possible and that product leadtimes are maintained.
  • Support site GPS projects.

Contact information:

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

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