Site Name: Ireland - Dungarvan
Posted Date: Jun 24 2021
We are currently looking to hire a Process Validation Specialist within the Technical Team. The Process Validation Specialist will provide technical validation support to resolve process issues within the Value Stream and in doing so will improve the process capability across the value stream. The role needs to support and positively impact site business objectives in relation to process understanding, optimisation and control. This role will report to the Technical Manager.
This is a two year contract based in our Dungarvan site.
As Validation Process Specialist, you will be responsible for:
- Provide validation support for process optimisation in the Value Stream and in doing so minimise the site waste exposure and improve RFT on site.
- Provide technical support to resolve manufacturing process issues in the Value Stream.
- Provide validation support to validate new products to ensure they comply with in house quality standards and the Quality Management System (QMS).
- Provide validation support to validate new suppliers of raw materials and finished products to ensure they comply with in house SOP's and the QMS.
- Co-ordinate and support the implementation of the Shipping & Distribution Validation programme in accordance with the QMS.
- Maintain the Technical reporting systems & databases.
- Support the data trending process.
- Support the Technical On-The-Job Training process & training records.
- Support the Technical Change Control Process for all process changes.
- Support the Problem-Solving Process (Deviation Process).
- Review & Update all Technical process team documentation in accordance with the QMS
- Support/input at key site plant meetings such as weekly process team meetings/ Value Stream meetings/line side meetings.
- Compile/present project updates at the monthly Technical Review meetings.
- Support/present updates at the one to one review sessions.
- Support/lead Technical Risk Assessments/FMEA's/generation of Product Control Strategy.
- Drive waste agenda for value stream responsible for or supporting.
- Setup/lead implementation teams for process changes and using effective meeting techniques.
- Raise recharge forms for relevant projects.
- Lead the implementation of NPI initiates across both OTC and OC sites at GSK Dungarvan and to ensure all New Product Introductions are developed in accordance with the principles of Design for Manufacturing (DFM) & Process of Understanding the Control and Capability (PUCC) such that all NPD which are transferred from R&D to the site are robust and capable processes which meet the Quality and Compliance standards required by GSK/HPRA/FDA and other major regulatory bodies.
- Lead the introduction of New Technology Platforms to support the site operational model as appointed.
- Lead the introduction of New Product families as per the site strategy.
- Lead the introduction of all Raw Material Source changes in accordance with Quality & compliance standards required by GSK/HPRA/FDA and other major regulatory bodies, to ensure ongoing assurance of supply & maximise all PPV opportunities as identified for the site formally.
We are looking for professionals with these required skills to achieve our goals:
- Third Level qualification in an Engineering Discipline or required equivalent experience.
If you have the following characteristics, it would be a plus:
- Working Knowledge of NPI / Process Validation Requirements within GxP environments; process optimisation changes; experience in providing technical support to resolve process issues within value streams.
- Project Management experience is desired.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
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