QC Analyst x2
Educated to primary or higher degree level-Chemistry or associated science.
2-3years experience in a pharmaceutical / healthcare industry.
Third level science-based degree (preferably post graduate).
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.
- 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.
You may apply for this position online by selecting the Apply now button.
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