Internship in External Quality for Students in Life Sciences

The Position

Mission of External Quality

• We serve our patients through external partnerships because access to quality products is every patient's right

• We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality

• We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide

• We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement

Main Purpose of the Internship Position

Support and learn to:

• Provide quality and compliance oversight for external GxP suppliers including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements

• Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.

Technical Job Responsibilities

Support and learn to:

• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions

• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements

• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate

• As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance

• As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP)

• As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs

• As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness

• As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches

• As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements

Functional Job Responsibilities

Support and learn to:

• Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.

• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.

• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.

• Sign documents as authorized and described by Roche policies, procedures and job descriptions.

• Be accountable for behaviors described in Roche's Code of Conduct.

• Deliver business outcomes in support of departmental objectives.

• Maintain and communicate work priorities to meet goals and timelines.

• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.

• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.

• Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement.

• Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations.

Qualifications and Skills

• You are enrolled in university in bachelor's or master's degree or finished your master's degree within the last 12 months within life sciences or equivalent

• Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus

• Experience with GxP suppliers such as CMO, CLO and direct material suppliers is a plus

• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals

• Ability to interpret quality standards as they relate to GxP suppliers

• Operational Excellence expertise is a plus

• Highly competent in MS office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc

• Ability to communicate clearly and professionally both in writing and verbally

• Fluency in oral and written English is a must. Additional language skills are a plus

How to apply:

• Please upload your CV and cover letter, and enrollment certificate if you are currently studying

• Please note that non-EU/-EFTA citizens need to provide an official letter from the university with their application documents stating that an internship is mandatory for their studies.

Details:

Start: As soon as possible

Duration: min. 6 months, preferably 12 months

Workload: 100%

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.