The pivotal role of the RP involves the technical oversight of pharmaceutical manufacturing processes, documentation maintenance, and adherence to legal requirements. Serving as the crucial link between the company and regulatory authorities, the RP must be independent in executing these responsibilities.
- Performing all tasks arising from Article 5 of the AMBV.
- Interface to the regulatory authorities (e.g. Swissmedic).
- Quality assurance
- Ensuring the required quality of the manufactured medicinal products.
- Reviews of critical deviations and OOS.
- Review and approval of GxP relevant SOPs.
- Preparation of audits and inspections.
- Handling of complaints and recalls.
- Market release of pharmaceutical end products and active ingredients.
- Technical release or decision on non-release of product batches
- Examination of legal requirements for the import and export of starting materials, packaging materials and medicinal products.
- Team training on regulatory requirements.