Main Responsibilities of the role

• Provide Validation input into engineering projects in accordance with GMP and SOP’s. This will require supporting the Project Engineers or Project manager to ensure the completion of key milestones and the monitoring of documented evidence which verifies that such milestones have been met..
• To lead all aspects of Validation programs for the company in order to meet appropriate GMP regulatory and validation requirements. Act as a Subject Matter Expert in area of responsibility.
• Provide a visual management system that will display a weekly and monthly output in a tier system
• Develop and improve the process of validating equipment onsite along with improving the current SOP’s. Update templates in the paper system so that easy transition will take place when paperless system goes live.
• Take an active role in helping to develop the validation strategy for site and our department with a view to reducing the current processes and streamlining them to greatly improve efficiencies.
• Actively set goals for your reports and follow the goals set by Line manager for career progression. 
• Co-ordinate/ perform utilities qualification studies. 
•  Co-ordinate/perform sterilisation/sanitisation validations studies. 
• Co-ordinate/perform thermal mapping studies. 
• Co-ordinate/perform transportation/distribution studies. 
• Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
• Contribute to the development of FAT/SAT protocols 
• Responsible for the introduction of several pieces of equipment across several facilities accommodating both the design and qualification of equipment
• Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
• Ensure all results and data are correct and follow-up on any gaps or discrepancies.
• Provide guidance and direction in the preparation and execution of validation activities

Requirements

• Third level degree in science or engineering
• A minimum of 5 years’ experience in a validation role the Pharmaceutical industry
• Experience in any or all of the following

1. 1. Thermal mapping of controlled temperature units
   2. Sterilisation validation of autoclaves and SIP
   3. Sterile manufacturing
   4. Cleaning validation
   5. Commissioning, Qualification & Validation of new systems and equipment
   6. Process Validation in Pharma, BioPharma or Medical Device Industries
   7. Utility qualification

QA Specialist – GMP Deviations 

Dolmen Engineering have a requirement for - QA Specialist for our Pharmaceutical client site in North West Dublin. The QA Specialist will be responsible for the initiation and investigation of GMP deviations, aimed at the identification of root causes, and the implementation of correct actions to prevent future recurrence.

The QA Specialist should demonstrate expertise in deviation investigations, and have an in-depth understanding of the manufacturing process so that guidance and direction for quality investigations and overall site deviation reduction is achieved.

Duties:

• Serve as a Quality SME for site deviation management system
• Lead and direct the daily activities required of the deviation investigation group to ensure a high quality and compliant investigation completed in a timely manner per standard timeline
• Ensure appropriate actions and escalations are being identified, and issues are resolved quickly and effectively. Ensure full compliance with GMP and Quality System requirements.
• Gather Data from various sources across the site and lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviations, Assessment of event for impact and Identification of Corrective and Preventative Actions to reduce deviation recurrence
• Perform and lead risk assessment activities
• Demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations
• Manage multiple projects and timelines concurrently, ensuring adherence to standard timelines, and escalate actions appropriately for resolution in a timely manner.
• Participate in the Daily Management meetings to update leadership on current deviation statuses
• Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interview
• Support the review and approval of site deviation and investigations reports.
• Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
• Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty, inclusive of complex technical topics.
• Mentoring and training of other Deviation Investigator / Initiators. Provide investigation guidance and expertise for complex deviation investigations to the team, as well as to associated cross functional teams in order to drive to root cause of the event

Requirements

• Bachelor of Engineering/Science (Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline)
• 5 – 10 years’ experience; Prior experience working or troubleshooting in a manufacturing environment, and technical writing experience required
• Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.
• Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11