Quality Assurance Audit Assistant Specialist

Contenuto del lavoro

About the Job

SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Responsibilities :

1. Check that the corresponding Change Control has an approved Action Plan containing the document, if a CC-number is associated with the document.

2. Check that reviewers and approvers are correct according to the Document Controls.

3. Work with Document Author, follow-up and carry forward the lifecycle of his/her documents and establish associations to the document.

4. Execute the archiving and obsolescing of quality records.

5. Responsible for timely, accurate and efficient preparation and management of document /record’s control.

6. Responsible for control of document/record numbering, sorting, filing, storing, distribution and retrieval of both electronic and hard copy documents.

7. Responsible to ensure documentations meets SHL requirement and required standards. (E.g: Check that the document formats correctly follow the SHL document template and released form)

8. Assist Quality engineers and QA managers for (a) Conducting regular document reviews (b) Support for improving of document control project / activities.

9. Responsible to ensure documentations meets SHL requirement and required standards. (E.g: Check that the document formats correctly follow the SHL document template and released form)

10. Perform data analysis to drive continuous improvement project to meet department/ company goal and objectives.

11. Assist quality audit readiness program and effort.

Skills & Qualifications

Required:

Able to work on documentation processing

Preferred:

with minimum ~1 year working experience

We offer

· Flexible hours and working from home policy.

· Modern working environment with state-of-the-art facilities and technologies.

· Challenging assignments in a fast growing and innovative industry.

· Position in a dynamic, international team of highly skilled professionals.

· Various opportunities for personal and professional development within a global organization.