QA Operations Shift Specialist
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QA Operations Shift SpecialistApply Now
This role will be part of our Manufacturing SDWT in our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. The QA Operations Shift Specialist role involves supporting the qualification/validation, technical transfers, regulatory approvals and commercial operations at the Takeda single use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for our rare disease Patients in Takeda, a patient-focused, values-based, R&D-driven global bio-pharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
The QA Operations Shift Specialist will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
The QA Operations Shift Specialist will be responsible for supporting the Operations team, ensuring compliance with cGMP and corporate regulations.
- Provide QA oversight to the qualification/validation, technical transfers, regulatoryapprovals and commercial operations at thefacility.
- Review/Approval of validation/Qualification/verification protocols and reports associated with new product or materialentry.
- Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercialmanufacturing.
- Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budgetmanagement.
- Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
- Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operation
- Liaises with internal partners (e.g. Manufacturing Operations, Process development Technical services (PD-TS), Engineering functions etc) in support of dailyoperations
- Ensures clear communication on issues and timely escalation asapplicable.
- Provide QA support to the manufacturing team onshift.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow upactions
- Champion site metrics to ensure targets are achieved, met and counter measures in place whenapplicable,
- Coordinate with peer internal Quality Groups to ensure on-time disposition of commercial drug substancematerial.
- Representing Quality on multidisciplinaryteams.
- Promote and exhibit TakedaValues.
- Executing companypolicies.
- Ensures new/revised quality system requirements are deployed to theSite.
- Ensures execution leads for Quality-owned business processes are established who subsequently work with the business process owner to continually improveprocesses.
- Ability to work on his/her own initiative in addition to working as part of a team and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines.
- Get actively involved by participating in inspections, GEMBA’s and Go-See’s.
- Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
- Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
- Routinely talk about any safety issues you are concerned about.
- Know the hazards of the tasks you are performing, actively conduct risk assessments for inclusion into operational SOPs.
- Challenge yourself before starting any task and identify safety improvements and be an active participant of our site safety standards challenging the status quo. If something is out of the ordinary, or something changes, step back and reassess; if in doubt do not do it.
- Challenge and identify improvements to the safety and environmental programmes on site.
- Ensure you are effectively trained for the work you need to do, challenge the safety training if it is not effective.
- Promote an environment where everyone speaks up for our culture of safety and looks out for one another.
- Be a visible leader of safety initiatives and stay actively involved in safety forums.
- The individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
- Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.
- Be an ambassador for the Takeda Values of Integrity, Fairness, Honesty , Perseverance.
- Provide coaching for your team members as part of the continuous improvement mindset
- Role model the behaviours that creates a culture of dignity and respect
- Identify improvement opportunities, perform technical troubleshooting and successfully implement solutions
- Support the implementation of site strategy and business unit strategy by identifying appropriate initiatives for applicable improvements to the value stream.
- In some instances, support corporate initiatives and projects as required.
- Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
- Get actively involved in supporting the implementation of the lean management system
- Ability to multi-task and handle tasks with competing priorities effectively.
- Excellent communication skills (written and oral).
- Be active in the external Network across industries to develop ideas that can be reapplied at Takeda Dunboyne Biologics.
- Encourage new and innovative approaches to improve the value stream.
- Utilise real-time data analytics for making decisions on the value stream improvement intiatives.
- Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.
- Create an environment of right first time in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
Education and Experience Requirements
- Minimum of a Bachelors Level 8 degree in a technical discipline (e.g. biochemistry, chemistry, engineering)or equivalent.
- Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
Key Skills, Abilities, and Competencies
- Demonstrate the Takeda Values of Integrity, Fairness, Honesty, Perseverance as a natural way of working.
- Strong project management skills to support project delivery and operational readiness.
- Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
- A proven ability to lead cross functional teams and deliver on tight timelines.
- Excellent influencing/collaboration skills and teamwork mindset.
- Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving.
- Ability to challenge the status quo with a continuous improvement mindset.Proven ability in using a wide variety of lean tools and building capability within teams.
- Change agent who will support the organisation with good change management tools and techniques.
- Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
- Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching.
- Effective communicator with a proven ability to grow talent and future leaders.
- Promoting a culture where diversity and inclusion is part of the DNA.Demonstrated ability to give and receive feedback.
- Enterprise mindset to ensure the right prioritisation for the site.
Complexity and Problem Solving
- Establishes stretch goals for self to allow the SDWT or Hub Team deliver on their priorities.
- Identifying and communicating risks in area of responsibility and across the site.
- Creating strategies and plans to manage risk within the value stream and SDWT and Hub teams.
Internal and External Contacts
- Collaborates across the Network and continuous improvement teams across the Organisation.
- Key collaboration with the Self-Directed Work Teams and Hubs across the enterprise.
- Collaborates with cross-functional teams to deliver the site objectives.
- For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Takeda and through external forums to drive business excellence.
Other Job Requirements
- This role is a site-based role.
- This role will involve shift work.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0045531