Documentation and Compliance Manager

vor 2 Wochen

Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Documentation and Compliance Manager** for a temporary contract of 12 months with a possible extension.

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's. 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.

**Tasks**:

- Act as a commercial complaint investigation support, evaluate the annual complaint analysis and support follow up activities, for example, Root Cause Investigations, subsequent Corrective Action and Preventative Actions (CAPA) and Change (Technical Change Management, Transfers, Capacity Expansion).
- Support or lead 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)
- 5 min. year proven track record of compliance management and documentation in the pharmaceutical or related industry
- Min. 5 years demonstrated track record in project management
- Strong GMP Knowledge
- Excellent communication and negotiation skills in German and English with success in building trustful relationships
- Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions
- Self-motivated, pro-active, responsible, result-oriented and an excellent team player
- Experience in working in agile environment and usage of lean tools

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