At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Basel, we are in search for a Document Manager.
Responsibilities:
- Documentation / QMS
- Implementation of documental changes for adaptation to Organon EMEA Hub, as captured in the MEMOs (140 docs total, including SOPs, JAs, FOs, templates – edit (from author)
- For all documents:
- Identification and reassignment of document ownership
- Support in upload, review and approval workflows in MIDAS of all docs
- 45 quality documents:edit, review; initiate workflows in MIDAS
- Establish / migrate SharePoint with links for direct access to MIDAS documents, for Organon EMEA Hub. SharePoint is already available and could be migrated (to be confirmed)
- ETQ Reliance - setup
- Support with project documentation (plan, reports)
- QMS Document preparation for migration to ETQ Reliance
- Pre-migration,Testing support (in test and production system),Hypercare (after spin)
- Routine upload of documentation in MIDAS from GSS / L-drive (CAPAs, Deviations, Quality Agreements, training matrix, training protocol, quality handbook, job descriptions)
- Maintenance of Trackers – deviations, CAPAs, change control, MIDAS workgroup access (duplicate and adapt), Job Description log, SOP Log, PQCs, Quality Agreements tracker, recall log, SC EMEA curricula
- administration of quality documents (archive / upload in MIDAS)
- Quality Agreements
- Maintain tracker
- Support duplication and adaptation for spin-off of Pan EU, Intercompany and global Quality agreements
- Support from a documentation perspective in the management of the deviations, CAPAs and change control systems as well as internal audits, health authority inspections and quality metrics reporting, at the EMEA Supply Chain Hub.
- Support with KPIs reporting (deviations, CAPAs, changes, regulatory inspections, quality plan, internal audits, supplier / customer qualification) – to be set up (Collate & Report)
- Training (SSO) (Support with set-up of training matrix, curricula and plan)
- System / Subsystem owners (Support the appointment of Systems/Sub-Systems Owners for Organon)
- Quality Risk Management (Support establishment local procedure for the EMEA Hub)
Qualifications:
- English speaker (German a plus)
- pharmaceutical quality background (min 1-2 years) and quality docs writing skills
- experience with Documentation systems / SharePoint
- Supply Chain experience is advantageous
- Excellent organizational skills,ideally project management experience
- Strong technical writing and verbal communication skills, as well as collaborative and leadership skills in dealing with a broad variety of cultures
- Demonstrated ability to work accurately, meet schedules and timelines, and handle multiple priorities
Nemensis AG
Basel