QA Contractor

We’re currently recruiting for an exciting opportunity with Biotechnology start up project based in Dublin . This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This position will focus on QA support in a few projects that are ongoing at the moment. Requirements will revolve around QMS activities e.g. change controls and completion of change actions, Quality agreements, SOP writing, preparation of documentation required to support regulatory submissions etc, CAPA tracking and close out.

Duties

•Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Participate in workshops and help with data gathering and knowledge sharing
• Support of Transcend project for the site regarding:
• Documentation
• Site Readiness activities
• Change Management
• Cutover planning
• Implementation execution
• Support of Hypercare
• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
• Carries out administration of the SAP Quality Management Module.
Carries out tasks relating to the management of site change control systems.
•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.
•Perform GMP audits on-site and vendor facilities as required.
•Previous experience with SAP
•Excellent interpersonal skills
•Ability to operate as part of a team is critical.


Education & Experience

•Bachelor’s Degree in a scientific/technical discipline required
•A minimum of 4-6 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
•Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
•Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
• Experience in auditing of external suppliers, contractors and vendors.

Any applicant must have an existing valid work permit/ visa to apply. (Stamp 4 or EU passport).

Contact ruth.holland @lifescience.ieor 087 7822 198 for more details.