We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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 is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP) with specific focus on the Transcend Project.
These activities include participation in project workshops, acting as a Site Change agent and support the Global Project Team regarding Training, Documentation, Site Readiness activities, Cutover planning, project execution and hyper care.
•Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
• 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.
• Participate in workshops and help with data gathering and knowledge sharing
• Support review and verification of the Core Model, challenging assumptions and identifying gaps
• Support design and verification of solutions proposed to address gaps
• Act as change agents in the Pharma TranSCend journey
• Support of Transcend project for the site regarding:
• 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.
•Excellent communication skills both written and verbal
•Attention to detail
•Good problem-solving skills
•Results and performance driven
•Adaptable and flexible
• Decision making
Education & Experience
•Bachelor’s 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.
• Experience in auditing of external suppliers, contractors and vendors.
This QA Specialist roles will focus on the implementation of the Global Transcend project to the Cork Large molecule site. Transcend will replace the current inventory management systems SAP. The main purpose of Transcend is to transform the supply chain from end to end. This will transform site based inventory systems into One Integrated systems which will allow:
•Delivery of unmatched customer experience
•Acceleration of new products
•Flexible adoption of external
•Use advanced analytics