This position is no longer open for applications

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:

1. 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.
2. 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
3. Review /Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR)
4. Issuance of Batch Records and Cleaning Records
5. Review of executed Batch Records and Cleaning Records as per site procedures.
6. Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
7. Quality Business Partner for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful transfer and validation of processes
8. 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
9. 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.
10. 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 instil a strong quality and compliance culture across the site.
• Assure the use of operational excellences 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 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.

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
• Recognised 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.