Website Ref: TPM04486
A QA Specialist is required for a biopharmaceutical company in Cork. The incumbent will be the key point of contact for all the project related activities including liaising with Global team and Senior Site management for the duration of the rollout project. Once the project is complete and the new system is fully stable they will revert to a QA role within the Quality training and System team.
- Lead or support the project by performing/co-ordinating all associated QA related tasks & assigned related tasks as per the project timelines in accordance with site procedures and GMP regulations.
- Provide QA advice and support as required.
- Inform QA management of project status, potential quality issues, and significant changes to current site practices.
- May conduct or serve as a lead/coordinator of deviations and CAPA recommendations.
- Supporting both training and QA systems.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- These may include the running and design of weekly metrics for Training, on Time Deviations, on time CAPA closure and change controls along with other QA metrics.
- This role may be responsible for the weekly delivery of GMP Induction training and may be required to design and deliver annual GMP Refresher training.
- Also deliver one to one GMP training when business needs arises.
- Exercises judgment within well defined and established procedures and practices to determine appropriate action – identifies problems and generates alternatives and recommendations within defined processes.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Acts as a mentor to junior staff in the System/Training team and will need to support a number of new staff as they come up to speed.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Qualifications & Experience:
- Relevant degree.
- Demonstrates excellent communication verbal & written skills.
- Demonstrates high level of project management skills.
- Demonstrates ability to prioritise and meet deadlines.
- Demonstrates advance technical knowledge of the GTrack systems.
- Excellent Computer Skills.
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