What you need to know
Matrix Recruitment Group are currently recruiting for a Senior Validation Specialist for our client in the Pharmaceutical industry based in Offaly.
Your new job
- Support continuous validation and compliance to the Site Validation Master Plan
- Interact with all levels of management and staff to oversee and facilitate the validation process from inception to completion
- Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment.
- Assist with Identifying the necessary internal and external resources for completion of validation projects and secure the necessary support (Production, QC, QA, outside contractors).
- Interface extensively with the QC/QA, Production and Engineering departments to identify projects and problems requiring validation support.
- Provide QA/compliance support to Cross functional teams to ensure that activities associated facility qualification and transfer of new products are in compliance with regulatory, corporate and site procedures and reviewing and approving transfer protocols, summary reports, strategy documents, qualification documentation, change control related documentation, master batch records etc.to support new product introduction.
- Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories, Engineering and outside contractors providing leadership, training and guidance as required
- Monitor and support the execution of the protocols through training, facilitating and problem-solving activities.
- Participate in and oversee site data integrity program and act as system administrator for key Quality Systems
- Own, lead and monitor execution of site Validation Master Plans and sub-plans and be responsible for site quality system governance
- Monitor validation activities to ensure they consistently remain in place, in use and in control, comply with Company Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices.
- Develop and use effective monitoring and control systems for process performance and product quality, providing assurance of continued suitability and capability of processes.
- Monitor Internal and External Factors Impacting Validation System (i.e. emerging regulations, innovations that might enhance the pharmaceutical quality system), to ensure compliance with the change regulatory environment.
- Assure the use of operational excellences tools in validation & quality procedures and processes.
- Immediate notification to the Quality Operations Manager of any quality issues, and provide accurate and relevant information as required by the business.
- Support the development of quality goals and targets as part of the organisation’s strategic plan.
- Drive continuous improvement qualification & validation initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology.
What are we looking for?
- Undergraduate degree in pharmaceutical, biological or chemical sciences
- Relevant advanced degree preferred
- 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with significant experience in QA validation activities
- Current knowledge of cGMP’s and regulatory guidance required with emphasis on all elements of validation e.g. equipment, process, analytical and computer validation.
- Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles
- Demonstrated knowledge and success in validation of Quality Systems
- Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team
- Exercises Good Judgment and Drives Change for Competitive Advantage
- Strong written and oral communication skills and ability to collaborate effectively with others
- Strong interpersonal, leadership and influencing Skills, communication and motivation
- Drives for Superior Results and Passion to Win with demonstrated record in getting things done
- Inspires Continuous Improvement and Breakthrough Thinking – flexible and adaptable to new and innovative ideas
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
- Business Awareness & Continuity
Apply for this job now via the link below
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