Responsible for performing the qualification / validation activities related to production before the start of associated activities
Analysing, documenting protocols and reports, directing validation activities, resolving issues encountered and making adjustments or improvements as and when necessary in coordination with cross functional team
Qualification and maintenance in a qualified status in accordance with the needs of internal customers and the requirements of the authorities to achieve quality / safety objectives during production.
- Coordinate the qualification on the site to:
- Integrate project groups and or conduct trainings in order to have a thorough knowledge of the modifications made or the capacities of the new installations (knowledge of technical and automatic requisitions, calculation notes, understanding of quality and regulatory constraints ...).
- Elaborate the qualification / validation tests and other requirements in relation with the internal customer, the quality department and the members of the project group.
- Develop and draft qualification / validation dossiers according to harmonized regulatory qualification rules / guidelines and obtain the approval of the files with the heads of the site.
- Take over with the technical teams (process, maintenance) the facilities and ensure the compliance of the files for provision by the service quality assurance.
- Ensure the qualification / validation are performed according to the protocols and completed in the given time
- Ensure that all systems are running according to the necessary specifications and operate within regulations to guarantee the production of quality and safety of products.
- Communicate the non-conformities and deviations encountered during the tests (thru organization of meeting), and coordinate the activities to allow the resolution of the blocking points at the earliest (problem solving, supplier contact)
- Lead the risk assessments to define the revalidation frequencies and ensure the follow-up and the good realization of this requalification / validation plan.
- Participate in the evaluation of the quality impact of each modification and lead the change control process to discuss and evaluate during Change Control meeting and take charge of the qualification actions resulting from these modifications.
- Define and follow the Validation Master Plans of the plant site in close collaboration with the Quality department.
- Participate and explain qualification strategy and associated records during customer audits and inspections.
- Increase the skills of the technical teams on qualification / validation trades through awareness and training.
Veronica, Shen Hwa Neo EA License No.: 02C3423 Personnel Registration No.: R1110855