Quality , Science, Pharmaceutical & Food
QA Systems Specialist – East Cork
PE Global is currently recruiting for a QA Systems Specialist for a client site in East Cork –
12 month initial contract
QA Specialist (Next Gen Project lead)
REPORTS TO: QA Systems and Training Manager
Job Purpose: The QA Specialist (Next Gen Project lead) will be the key point of contact for all Gtrack next Gen project related activities including liaising with Global team and Senior Site management for the duration of the NextGen rollout project. Once the project is complete and the new system is fully stable they will revert to a QA11 role within the Quality training and System team.
MAIN DUTIES & RESPONSIBILITIES
- Lead or support the NextGen 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.
KEY COMPETENCIES REQUIRED:
- Demonstrates excellent communication verbal & written skills
- Demonstrates high level of project management skills
- Demonstrates ability to work effectively in a team environment.
- Demonstrates an ability to effectively communicate with cross-functional peers.
- Demonstrates ability to prioritise and meet deadlines.
QUALIFICATIONS & EXPERIENCE:
- Excellent Communication & Interpersonal skills
- Exemplary attendance and time-keeping record
- Excellent Computer Skills
THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES
Interested candidates should send their CV to Audrey.firstname.lastname@example.org or call 0214297900