QA_ Audit Assistant_(1 year contract)

Contenuto del lavoro

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. The strong competition around the globe, comes from the Intelligence property we owned in Europe and USA, the vertical integration from the tool design, to state of art industrial 4.0 footprint throughout the processes and great QMS/RA intelligence to ensure we deliver the most reliable products. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Job Overview:

1. Support clean-up of Phase 1 PLM – Documentation error due to system bugs/limitation

2. Support Document control reporting and data analysis.

3. GDP improvement activities

Main 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.

Required Skills & Qualifications:

- Able to work on documentation processing & data analysis.

- With minimum ~1 year working experience.

We Offer

• An exciting opportunity in a fast-growing international medical device company

• A modern working environment, with multicultural and dynamic teams

• Flexible working hours and a hybrid remote work policy

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including CV and all other relevant documents.

For more information on SHL Medical, please visit our website: www.shl-medical.com

Is this not quite what you are looking for? Further interesting career opportunities can be found on our SHL Career page: www.shl-medical.com/careers

Please note: For this position we do not consider applications from recruitment agencies.