Quality Documentation Associate

Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,400 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.

Ensuring document management in compliance with specifications (updating, archiving and maintenance)

1. General document distribution (posting, monitoring up-to-dateness)

2. PMF document distribution incl. updating of PMF's (administration of new drawings, new SOP's, etc.)

3. Support in the preparation of documents (SOP, inspection plan MES, etc.) regarding compliance with the specifications (e.g. standardized test plan)

4.  Key user in the plant for Roxtra (uploading site documentation)

5.  Document exchange with customers (e.g. eRoom, Sharepoint)

6. Training documentation (on the relevant systems): Maintain site-specific documents, Maintain and evaluate training status of quality employees, Archiving and Documentation (WEK, IPC, manufacturing records, final inspection, PMF, etc.) ·

7. Inspection free supplier

8. Release and retention pattern 

9. Test sample (e.g. from validation)

10. Proper destruction after expiration of the archiving period

11. Ensuring accuracy and completeness of documents is crucial, requiring a keen eye for detail. ·

12. Communication Skills: Clear and concise communication is essential for conveying information to stakeholders and collaborating effectively. · Document Management Proficiency: · Experience with document management systems (DMS) and software is vital for organizing, storing, and retrieving documents efficiently. · Compliance: · Understanding and adhering to relevant regulations and standards is essential for maintaining document integrity.

Knowledge as acquired during 3 years of vocational training (technical / commercial) and enhanced by 2 years of professional experience in the field of quality assurance.

• Good knowledge of document management and archiving (form, deadlines, destruction) and GDP • Good knowledge general office and administrative activities

• Proficient with standard MS Office applications for analyzing and reporting information

• Knowledge of regulatory requirements and standards preferred

• Performance and design motivation

• Excellent people skills, including verbal and written communications, at all business and customer levels

• Technical Writing and Editing: The ability to create clear, concise, and accurate documentation is important. Data Entry and Filing: Accurate data entry and organization of documents are essential. Technical understanding of version, change control and audits preferred

• Analytical competence and ability to communicate and pass on knowledge

• Problem solving techniques

• Basic knowledge of English (spoken and written)

All your information will be kept confidential according to EEO guidelines.

M-F 8am-5pm 

Hourly position 

401k, full benefits