▷ (Immediate Start) QA Operations Specialist

Our Client Our client is a leading animal pharmaceutical company based in County Wicklow. POSITION SUMMARY This position will report directly to the Rathdrum Site Quality Operations (QO) Lead and will serve as partners alongside other stakeholders to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready. The Rathdrum QA Specialist-Operations will have responsibility for ensuring that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with cGMP and the associated regulatory requirements. The QA Specialist- Operations may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Batch Release on a case-by-case basis where needed, once trained to do so POSITION RESPONSIBILITIES Key objectives of this position include: Provision of Quality oversight and support for Operations in the following key area/activities; manufacturing, testing, packaging and material management across all phases of development and commercial manufacture in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures. Provide in plant/on the shop floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities including but not limited to Batch Manufacturing and Analytical Testing, Deviations, Change Control, CAPA's and Training Review /Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR) Issuance of Batch Records and Cleaning Records Review of executed Batch Records and Cleaning Records as per site procedures. Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc. Quality Business Partner for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful transfer and validation of processes Quality Business partner for Engineering Change Control and Equipment Calibration and Qualification and Facility Recommissioning (CQV) to ensure Qualified equipment and Facilities are provided to Operations for Batch Manufacture Quality Support for Utilities and Facility Support Systems E.g. Water, Nitrogen, Environmental Monitoring and Cleaning Validation Systems. Support in ensuring compliant systems and processes are in place, validated and executed as intended. Support in Councils and Team meetings to ensure data is trended and all deviations are investigated and changes assessed. QA Release of Intermediates Common Responsibilities for all Quality Colleagues Active participation in site Tier meetings Perform/Lead Internal Audits/Quality Walkthroughs. Support Internal Inspection Readiness, Corporate and Regulatory Inspections. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met Serving as a quality culture role model and instill a strong quality and compliance culture across the site. Assure the use of operational excellence tools in quality procedures and processes, Support the development of quality goals and targets as part of the organisation's strategic plan, Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others. Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner. Perform role to a high standard and deliver on all assigned objectives/duties. SYSTEM OWNER / SUBSYSTEM OWNER RESPONSIBILITIES System Owner (SO) System Owners have overall accountability for the site Quality Systems for which they are responsible and in particular for: * Providing strategic & proactive direction with respect to the System (across the site) in terms of content and execution. * Providing support, guidance & coaching to Sub System Owners (SSO). * Ensuring that SSO regularly review sub-systems for their effectiveness, escalating issues where required to site Quality Council (QRC) for action & remediation. * Owning relevant System issues in the site Compliance Plan. * Defining resources as needed & communicating resource needs to Site Lead. * Applying people change control across Sub-Systems within their responsibility. * Ensuring that SSO have proactive continuous improvement plans for their Sub-Systems. Sub System Owner (SSO) Sub-System Owners have overall accountability for the site Quality Sub-Systems for which they are responsible and in particular for: * Providing strategic & proactive direction with respect to their Sub-System (across the site) in terms of content and execution. * Regularly reviewing their Sub-System & presenting Sub-System review to Quality Council (QRC) as required. Escalating issues where required to the System Owner (SO) and site QRC for action and remediation. * Owning relevant Sub-System issues in the site Compliance Plan. * Defining resources as needed & communicating resource needs to SO. * Developing & implementing proactive continuous improvement plans for their sub-system. * In partnership with the SO, ensuring that there are clearly defined expert(s) for each sub-system, acting as a point of contact during inspections. * Overseeing all documents associated with their sub-system and providing input to the document owners during updates. * Providing comments on new/revised draft policies and guidelines and completing impact assessments where required. ORGANIZATIONAL RELATIONSHIPS This position will need to achieve results through colleagues with a direct reporting relationship as well as indirectly, as part of the site recommissioning core project team through to commercialisation. All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures. All employees are expected to model inclusion behaviours. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions. EDUCATION AND EXPERIENCE Undergraduate degree in pharmaceutical, biological or chemical sciences Relevant advanced degree preferred 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of cGMP's and regulatory guidance required. Significant experience in Equipment Commissioning/ Qualification, Cleaning Validation and Process Validation is desirable. Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles ICHQ7 Manufacturing Site experience preferred Recognized LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable TECHNICAL SKILLS AND COMPETENCIES REQUIRED Demonstrated knowledge and success in working with cross functional teams e.g. supplier management. 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 Proficient in English Demonstrated written communication skills, as well as experience with presenting to leadership teams. Assertive Business Awareness & Continuity PHYSICAL POSITION REQUIREMENTS This is Rathdrum, Ireland Site based position Travel may be required as part of the role, as needed to support audits - approx. up to 10% of the time. This position will require fluent use of teleconferencing tools, as well as SharePoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003 Skills: Quality Change controls batch record review