Documentation and Compliance Manager

vor 2 Wochen

Basel, Schweiz We make it GmbH Vollzeit

We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT.

We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company F. Hoffmann La Roche based in Basel, we are looking for an Documentation and Compliance Manager (M/F/d).

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.

across functions and geographies.

Aufgaben
- 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) expertis
- Continuous optimization of performance and striving for excellence
- Manage Onboarding of new employees and manage training system

Qualifikation
- 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 haves
- proven track record of compliance management and documentation in the pharmaceutical orrelated industry

Work hours
- 40 h / Standard

Are you interested?

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