Rp Deputy

**Site Name**: Switzerland - Muenchenbuchsee Bern

**Posted Date**: Apr 25 2023

We are transforming medicine and improving the health of the world. And we do it with the highest integrity and care because billions of people are counting on us. We want exceptional people who want to achieve ambitious objectives. Our ability to launch and market new products successfully and grow sales from our existing portfolio is key to our commercial success. But we believe what we do isn’t only about the numbers, it’s also about finding new ways to drive business performance and deliver greater value to patients.

This is your opportunity to join our exciting and very dynamic team as a:
**_ Responsible Person Deputy - RP Deputy _**:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
**_ Responsibilities_**:
**Responsibility as Responsible Person Deputy**
- Issue directives regarding quality processes for local operations and ensure
appropriate procedures and handling of medicinal products in compliance with regulations and local law according to Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1) art. 4, art. 5, art. 7, art. 13, art. 15, art. 16 and art. 17.
- Ensures that medicinal products and medical devices for the companies GlaxoSmithKline AG (GSK) and ViiV Healthcare GmbH (ViiV) as MAHs are manufactured, imported, released, stored and distributed in Switzerland according to GMP, GDP and local regulatory requirements. Ensures that release documentation is archived accordingly.
- Takes decision about batch release or rejection independently from local business management.
- Coordination and oversight of GDP and quality-related processes of the external pre wholesaler (Alloga).
- Preparation of RP declarations for confirmation of GMP compliance for APIs, drug products and finished products manufacturing sites for product registration or variations. Issuing of RP declaration in absence of LOC Responsible Person.
- Supports recall management.
- Reports Quality Defects to the regulatory authority according to Swiss legal requirements in absence of LOC Responsible Person.
- Technical evaluation of product complaints. Responsible for complaint handling with manufacturing sites, Pharmacovigilance and Customers.
- Approves periodic product reviews/local evaluation reports.
- Supports LOC Responsible Person during inspections (Swiss medic/RHI).
- Responsible for management of repacking activities.
- Reviews and approves quality agreements/technical terms of supply (QAAs/TTS).
- Reviews and approves distribution risk assessments (DRAs).
- Handling of Distribution Incidents.
- Responsible for qualification of GMP/GDP suppliers and customers.
- Handling of product returns and decision on release or rejection.
- Deputize LOC Responsible Person in his/her absence.

**Responsibility for the QMS**

Quality Management System (QMS) - Supporting implementation and maintenance of an effective QMS to ensure that local operations are in full compliance with GMP and GDP and local regulatory requirements in Switzerland. Ensures that the QMS is in compliance with GSK standards and policies.

Following QMS processes are in scope:

- QMS Implementation
- Management Review/Quality Council
- Risk Management
- Change control
- Self-inspection and Auditing
- Corrective and preventive action (CAPA)
- GxP 3rd Party management
- Quality Agreement and TTS
- Training
- Document Management
- Deviations
- Periodic Product Review
- Distribution incident management
- Product release
- Repacking
- Complaints
- Returns
- Incident management
- Anticounterfeiting

**_ Why you?_**:
**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- University degree as a pharmacist or in the area of natural sciences
- Minimum of 3 years experience within the Pharmaceutical / Consumer Healthcare or similar industries, preferably in the capacity of a senior quality specialist or a manager
- Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
- Strong knowledge of regulatory requirements pertaining to
GMP/GDP
- Good knowledge on effective quality documentation systems

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
- Ability to influence and motivate stakeholders at any level of the LOC organization
- Analytical mind, good attention to detail and problem solving skills within a structured process
- Good team player - works well in cross-functional teams
- Good time management skills, with ability to multi-task and work under pressure
- Concise and pe