- Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- Degree in Project Management field and/or 2-3 years related experience and/or training will be beneficial.
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
- Ability of task prioritization.
- Ability to display a willingness to make decisions.
- Ability to work in fast-paced environment and adapting to changing circumstances.
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Product Change Co-Ordinator - Stamullen, Ireland - PCI Pharma Services
Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Job Title: Product Change Co-Ordinator
Department: Product Change Management Department
Accountable to: Manager of Product Change Management Department
Accountable for:
Implementation of the changes to commercial product as requested by the client
Summary of Objective:
Manages designated customer projects and serves as primary point-of-contact for the change tracking purposes to ensure that goals and objectives are accomplished within agreed time frame and budget while adhering to applicable regulations and protocol requirements. Supports maintaining exceptional client satisfaction and superior business performance metrics. Leads and plays an integral part in individual project success.
Essential Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The essential duties and responsibilities include the following but other duties may be assigned.
Key Responsibilities:
1. Lead any scope changes to repeat work where appropriate.
2. Serve as the primary customer contact for Change Requests activities including artwork change,
Bill of Material update and new SKU introduction, material change for components that requires
re-validation.
3. Raising and coordinating Change Control creation for the project and aligning with internal
departments as required.
4. Track artwork development to ensure on time change implementation.
5. Review current open order book to establish the impact of the change to upcoming production.
6. Track and report on the progress of the change.
7. Project Management from start to end. (Until change is implemented and documentation
updated accordingly.)
8. Monitor impact of the change to the current stock level within the customer portfolio and advise
customer of the potential implications like cost of the material.
9. Manage customer expectations and general change related inquiries.
10. Support customer change related visits and/or Microsoft Teams meetings with PCI Team.
11. Host regular status/progress reviews with the Customer directly linked with the Change
Implementation.
12. Maintain the relationship with the customer. Acquire a comprehensive understating of key
customer needs directly linked with the project management.
13. Maintain customer files to have full traceability of the change.
14. Maintain the ERP database - to include latest Technical Agreement, Service Level Agreement,
Delivery / Address changes etc.
15. Ensure compliance of the change with Master Service Agreement objectives.
16. Issue Change associated documentation and obtain approvals as required.
17. Coach, mentor, and supervise colleagues within the same department as required.
18. Participate in and provide necessary information for Business Review meetings as required.
19. Participate in continuous improvement projects.
20. Training and onboarding of new employees within same role, as requested.
21. This position may require overtime and/or weekend work upon the agreement with the
department manager.
22. Knowledge of and adherence to all PCI, cGMP, and policies, procedures, rules and
documentation required.
23. Performs other duties as assigned by Manager/Supervisor.
24. Utilize key software platforms to facilitate client data reporting and project status.
25. Support other functions including quality calls and audits - be aware of quality issues.
26. Be familiar with Technical and Commercial Agreements and ensure they are referred to when
generating documentation for example Packaging Instruction Sheets
27. Increase market awareness and intelligence via trade shows, LinkedIn and customer discussion.
28. Commercial packaging co-ordination and New Product Introduction process are outside of the
scope of work.
29. Co-ordination of Procurement of components for commercial packaging is outside of the scope
of work.
30. Work in a safe manner always and highlighting any safety issues to relevant manager.
Qualifications: The requirements listed below are representative of the knowledge, skill and/or ability
required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Preferred:
Join us and be part of building the bridge between life changing therapies and patients.
