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QA Specialist

Posted on Jan 17, 2019 by Anonymous

Cork, Cork Ireland
Engineering
Immediate Start
Annual Salary
Full-Time
Contact: Orla Crowley Healy
Email:
Telephone:

QA Specialist 12-month Contract Cork

Our client, a medical device company in Cork are currently looking to recruit a QA Specialist for their site on a contract basis.

Description:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.

Responsibilities:
• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Batch Record Review & material release to ensure compliance with GMP requirements.
• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
• Carries out tasks related to the management of batch records design and approval.
• Carries out administration of the SAP Quality Management Module.
• Carries out tasks relating to the management of site change control systems.
• Compiles Annual Product Reviews.
• Supports all validation activities on site as described in the Site Validation Master Plan.
• Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
• Supports system qualification and process validation activities.
• Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
• Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
• Perform GMP audits on-site and vendor facilities as required.
• Carries out tasks related to the administration of site supplier approval process.

The Ideal Candidate:
• Excellent interpersonal skills
Ability to operate as part of a team is critical.
Customer focus
Excellent communication skills both written and verbal
Good problem solving skills
Results and performance driven

For further information on this QA specialist role in Cork please contact Orla Crowley Healy /
Check out all our open jobs on our HERO Recruitment website - (url removed)

Please Note: HERO Recruitment will not forward your details to any company without your prior approval

Reference: 619563084