Documentation and Compliance Manager (f/m/d)

Documentation and Compliance Manager (f/m/d) – Project Management / agile / Health Authority / medical device / German

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Documentation and Compliance Manager

Background:
Within the department, the chapter Product Care/Documentation and Compliance is accountable for Technical Support of marketed Combination Products and Medical Devices, Post Launch Changes, Complaints and DHF Maintenance, input to APQR/PSQR, Remediation. The Documentation and Compliance activities include the departmental training concept and onboarding of new employees, SPOC for PQS and Quality systems, departmental archiving concept, records & data management and coordination of self-inspections/audits.

The perfect candidate has a degree within life sciences and first experiences in compliance management and documentation within the pharmaceutical industry. Additionally, the candidate is someone who wants to influence his/her own development and can work independently, with limited supervision. The person is looking for a company where they have the opportunity to pursue their interests across functions and geographies.

Tasks & Responsibilities:

-Acts as a commercial complaint investigation support, evaluates the annual complaint analysis and supports follow up activities, for example, Root Cause Investigations, subsequent Corrective Action and Preventive Actions (CAPA) and Changes (Technical Change Management, Transfers, Capacity Expansion).
* Supports or leads technical Changes e.g. Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
* Manage the Product Care Annual Review (PCAR)
* Ensuring regulatory compliance and Roche internal GMP standards (e.g. departmental archiving concept, records management and training)
* Interpret Pharma Quality System requirements into local operational processes
* Support internal/external Quality/Regulatory/SGU inspections
* (Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertise
* Continuous optimization of performance and striving for excellence
* Manage Onboarding of new employees and manage training system

Must Haves:

Bachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and first experiences in the pharmaceutical or a related industry
* Demonstrated track record in project management
* Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices
* Experience with Health Authority interactions
* Excellent communication and negotiation skills in German and English with success in building trustful relationships
* Self-motivated, proactive, responsible, result-oriented and an excellent team player
* Experience in working in agile environment and usage of lean tools

Nice to Have:
* proven track record of compliance management and documentation in the pharmaceutical or related industry

Reference Nr.: 922807SGR
Role: Business Intelligence Specialist
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: 18.09.2023
Duration: unlimited

Deadline: 14.08.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.