This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required 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.
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.
* Bachelors Degree in a scientific/technical discipline required
* A minimum of 3-5 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.
For a confidential discussion or further information, please contact Emer on 0860437889